Nationwide and Canada to distributors and consumers.
Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by:  Zi Xiu Tang Success, LLC., Trexlertown, PA  18087, UPC 6 937000 700019
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by:  Zi Xiu Tang Success, LLC., Trexlertown, PA  18087, UPC 7 9357304140 1
Nationwide Distribution including AK, AL, AR, AZ, CA, DC, FL, GA, IA, IL, LA, MD, MI, MO, MS, NC, NH, NJ, NM, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA,  and WI.
Dimension(R) TACR Flex(R) reagent cartridge (DF107)   The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management of Tacrolimus therapy in kidney and liver transplant patients
Siemens Material Number 10444938, lot numbers GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267 and FB3267.
Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD.  The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme.  The firm name on the label is Remel Europe Ltd., Dartford, England.   Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
The product may give weak or false negative test results.
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box.  The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan.
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B.       Product Usage:  For the biochemical identification of medically important yeast and yeast-like organisms.
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Product was shipped to the following states: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WI & WV.
Everpet Real Chicken Chicken Chips Dog Treats, packaged in flexible plastic bags, 3.5 oz. per bag, MADE IN CHINA  DISTRIBUTED BY DOLGENCORP, INC. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 UPC 8 10633 01177 5
Lot #111108EVPRAW013 - Best Buy Date:  2/5/2013 and Lot #120752EVPRAW013 - Best Buy Date:  8/27/2014.
The New York State Department of Agriculture & Markets (NYSDAM) found trace amounts of non-approved antibiotic residue in some of the dog treat samples that they tested.
Hubbard Life Homestead FASTGROW AM.0.0125 NAB/NAB MEDICATED Complete Chicken Starter/ Grower/ Finisher/ Broiler Feed, Complete Turkey Grower/ Finisher    Aid in prevention of coccidiosis.  ACTIVE DRUG INGREDIENT AMPROLIUM 0.0125 %
Item No.: 34739-2 and Lot Number: B00570987
Hubbard Feeds Inc. announced today a voluntary recall in Indiana and Michigan Due to Potentially Elevated Calcium and Phosphorus in one lot of Hubbard Life Homestead FASTGROW AM.0125 NAP/NAB MEDICATED which may be harmful to chickens and turkeys.
Nationwide Distribution including AL, CA, CO, FL, IA,  KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box.  The firm name on the box label is Oxoid Ltd., Basingstoke, UK.   Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Boxes labeled as CIP5 may contain cartridges of AMP5.
Healthy Life Chemistry Inc dba Purity First
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Approximately 30% of all finished products were sold to customers in interstate to include but may not be limited to NY, NJ & CT via UPS.  Products are promoted and sold directly to customers at Healthy Life Chemistry's retail store at 13A Lucon Drive in Deer Park, NY, on the company website (www.purityfirst.com), and are available at the health food store, Total Health, located at 120 Rte 110, Farmingdale, NY (www.totaldiscountvitamins.com).
B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735; 1-800-696-7017
Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.
This product was distributed within the contiguous 48 states.
Dogswell Breathies Minis Chicken Breast Mint &  Parsley, 5 oz.    Packaged: plastic pouches.    Ingredients: Chicken Breast, Vitamin E Supplement, Mint,  Cinnamon Bark, Oyster  Shell Flour (Source of Calcium Carbonate), Rosemary,  Parsley, Chlorophyll.
UPC 884244112428 All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell, LLC initiated this recall of certain Dogswell and Catswell pet treats because they have the potential to contain trace amounts of an antibiotic that has not been approved for use in the United States.
Dogswell Breathies Chicken Breast with Mint & Parsley, 5oz, 15oz, 32oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, Mint,  Cinnamon Bark, Oyster  Shell Flour (Source of Calcium Carbonate), Rosemary,  Parsley, Chlorophyll
Dogswell Breathies Duck Breast with Mint & Parsley, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Duck Breast, Vitamin E Supplement, Mint, Cinnamon  Bark, Oyster Shell  Flour (Source of Calcium Carbonate), Rosemary,  Parsley, Chlorophyll
UPCs 884244112435, 884244115436  All Lots with Best Before dates 1/28/2015 and earlier.
Catswell Breathies Chicken Breast with Mint & Parsley, 2oz.    Packaged: plastic pouches.      Ingredients:Chicken Breast, Flaxseed, Vitamin E Supplement, Mint,  Cinnamon Bark, Oyster Shell Flour (Source of Calcium  Carbonate), Rosemary, Parsley, Chlorophyll
UPC 884244000589 All Lots with Best Before dates 1/28/2015 and earlier.
Catswell Happy Hips Chicken Breast Glucosamine &  Chondroitin, 2oz.    Packaged: plastic pouches.      Ingredients:Chicken Breast, Glucosamine Hydrochloride,  Chondroitin Sulfate, Vitamin E Supplement
UPC 884244000565 All Lots with Best Before dates 1/28/2015 and earlier.
Catswell Vitakitty Chicken Breast with Flaxseed &  Vitamin A, 2oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, Flaxseed,  Vitamin A Acetate.
UPC 884244000572 All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Happy Heart Chicken Breast with  Flaxseed and Taurine, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, Flaxseed,  Taurine, Turmeric, Cinnamon, Dandelion Oil.
UPCs 884244112619, 884244115610   All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Happy Hips Chicken Breast Glucosamine  & Chondroitin, 5oz, 15oz, 32oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vegetable Glycerin, Vitamin E  Supplement, Glucosamine  Hydrochloride, Chondroitin Sulfate.
Dogswell Happy Hips Duck Breast Glucosamine &  Chondroitin, 5oz, 15oz, 32oz.    Packaged: plastic pouches.      Ingredients: Duck Breast, Vegetable Glycerin, Vitamin E  Supplement, Glucosamine  Hydrochloride, Chondroitin Sulfate.
Dogswell Mellow Mut Chicken Breast, 5oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, Chamomile,  Clover Lavender, Lemon Balm, Linden Flower, Oyster Shell Flour (Source of Calcium Carbonate).
UPC 884244112510.   All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Mellow Mut Chicken Breast Chamomile  & Lavender, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, Chamomile,  Clover, Lavender,  Lemon Balm, Linden Flower, Oyster Shell Flour  (Source of Calcium Carbonate)
UPC 884244115511.   All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Mellow Mut Chicken Breast Natural with  Added Vitamin E, 32oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, Chamomile,  Clover, Lavender,  Lemon Balm, Linden Flower, Oyster Shell Flour  (Source of Calcium Carbonate).
UPC 884244118512. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Shape Up Chicken Breast with LCarnitine, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vitamin E Supplement, LCarnitine,  Dried Kelp, Dandelion Oil, Ginger, Turmeric.
UPCs 884244112817, 884244115818. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Veggie Life Happy Hips with Glucosamine &  Chondroitin Chicken &  Apple, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Apple, Vitamin E Supplement,  Glucosamine Hydrochloride, Chondroitin Sulfate.
UPCs 884244005102, 884244135151. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Veggie Life Happy Hips with Glucosamine &  Chondroitin Chicken &  Banana, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Banana, Vitamin E Supplement,  Glucosamine Hydrochloride, Chondroitin Sulfate.
UPCs 884244005089, 884244135144. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Veggie Life Happy Hips with Glucosamine &  Chondroitin Chicken &  Sweet Potato, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Sweet Potato, Vitamin E Supplement,  Glucosamine Hydrochloride, Chondroitin Sulfate.
UPCs 884244005041, 884244135137. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Veggie Life Vitality with Flaxseed & Vitamins  Chicken & Apple, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Apple, Vitamin E Supplement,  Flaxseed, Vitamin A Acetate.
UPCs 884244005119, 884244135250. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Veggie Life Vitality with Flaxseed & Vitamins  Chicken & Banana, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Banana, Vitamin E Supplement,  Flaxseed, Vitamin A Acetate.
UPCs 884244005096, 884244135243. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Veggie Life Vitality with Flaxseed & Vitamins  Chicken & Sweet Potato, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Sweet Potato, Vitamin E Supplement,  Flaxseed, Vitamin A Acetate.
UPCs 884244005058, 884244135236. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Vitality Minis Chicken Breast Flaxseed &  Vitamins, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vegetable Glycerin, Vitamin E  Supplement, Flaxseed,  Vitamin A Acetate.
UPCs 884244112220, 884244115221. All Lots with Best Before dates 1/28/2015 and earlier.
Dogswell Vitality Chicken Breast with Flaxseed &  Vitamins, 5oz, 15oz, 32oz.    Packaged: plastic pouches.      Ingredients: Chicken Breast, Vegetable Glycerin, Vitamin E  Supplement, Flaxseed,  Vitamin A Acetate.
Dogswell Vitality Duck Breast with Flaxseed &  Vitamins, 5oz, 15oz.    Packaged: plastic pouches.      Ingredients: Duck Breast, Vegetable Glycerin, Vitamin E  Supplement, Flaxseed,  Vitamin A Acetate.
UPCs 884244112237, 884244115238. All Lots with Best Before dates 1/28/2015 and earlier.
Nationwide, Puerto Rico, and internet sales
Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, FL, GA, IL, MN, MO, NY, PA, TN, TX, VA, and Canada.
KayserBetten model IDA beds   Product Usage:   BED, AC-POWERED ADJUSTABLE HOSPITAL
Some joints on the doors of a limited number of IDA beds may loosen or separate over time which can cause the doors to drop outward and cause injury.
Purina GATES LON Complete PEL DBZ7.2 with Diflubenzuron
Dairy cattle feed was manufactured with toxic levels of Monensin.
Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in 1 capsule per blister pack, Distributed by: 72HP, Inc. Weston, FL
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied in 1 capsule per blister pack, Distributed by MSH Distribution LLC
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0.
Lot #: 11440, Exp 09/13, labeled for CVS; 11441, Exp 09/13, labeled for CVS; 12042, Exp 01/14, labeled for CVS and Wal-Mart ; 12103, Exp 02/15, labeled for Wal-Mart; 12203, Exp 05/15, labeled for CVS and Wal-Mart; 12207, Exp 05/15, labeled for Wal-Mart; 12293, Exp 08/15, labeled for Wal-Mart; 12352, Exp 09/15, labeled for CVS and Target; and 12356, Exp 09/15, labeled for CVS and Target.
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Share a Smile Mixed berry Anti bac Justice,  Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Made in China
FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol,  Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
I LOVE BACON Justice,  VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5
0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge   The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream Size 1 Pint (473 ml) packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream  Sell By Date:10/04/2014
Turkey Hill Dairy is initiating a voluntary recall on the Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream, Sell By Date:10/04/2014, because the product may be potentially contaminated with metal debris.
Turkey Hill Stuff'd  Moose Tracks Frozen Dairy Dessert Size: 1 Pint (473 ml), packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
Turkey Hill Stuff'd  Moose Tracks Frozen Dairy Dessert  Sell By Date:  9/27/2014
Turkey Hill Dairy is initiating a voluntary recall on Turkey Hill Stuff'd  Moose Tracks Frozen Dairy Dessert, Sell By Date:  9/27/2014, because the product may be potentially contaminated with metal debris.
Turkey Hill Pumpkin Pie Premium Ice Cream 48 oz. packaged in a paper tub and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
Turkey Hill Dairy is initiating a voluntary recall on Turkey Hill Ice Cream because the product may be potentially contaminated with metal debris.
Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
VITROS CA 125 II Calibrators   For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
Access Immunoassay Systems Reaction Vessels.   The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System ''Wash Carousel Motion Errors'' with specific lots of Access System  Reaction Vessels (RVs). If your system is experiencing these errors, the  errors will be documented in the event log and the system will be in the Not  Ready mode.
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
Blood Center of Northcentral Wisconsin, Inc.
Blood products, labeled with incorrect or missing information, were distributed.
Blood product, labeled with incorrect or missing information, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
Continuous Peripheral Nerve Block Catheter Kit and Set   Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570,  RF2069779, RF0088984,  RF2108983, RF0128588,  RF3052266, RF1071764.
A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood products, in which donor testing was not performed or incomplete, were distributed.
Penrose-St Francis Health Services Blood Bank
Blood products, collected from a donor who reported a history of Hepatitis, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood Bank Of San Bernardino And Riverside Counties
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton.  UPC 6 949682 801731.  *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: CHANG RONG INTL BAYONNE NJ 11213.  PRODUCT OF CHINA.  *2nd label indicates: Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002.  PRODUCT OF CHINA.
LSG Food World Inc., has recalled Noodles House Home Style Noodles due to use of unapproved color and undeclared food additive.
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton.  UPC 6 949682 801724;  *1st label indicates: Manufactured by: JINYYIFAN(HK)INTERNATIONAL LIMITED RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: CHANG RONG INTL BAYONNE NJ 11213.  PRODUCT OF CHINA.  *2nd label indicates: Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002.  PRODUCT OF CHINA..
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton.  UPC 6 949682 801748; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002.  PRODUCT OF CHINA..
NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton.  UPC 6 949682 801755; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: S&M INT'L INC 100 PULASKI ST, BAYONNE NJ 07002.  PRODUCT OF CHINA..
Worldwide Distribution - USA including WI, UT, ND, MT, WA, CA, OK and Internationally to Australia, Canada, and Germany.
Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by  Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific    The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.
Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received.
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs,    GE Healthcare Finland Oy  Kuortaneenkatu 2  FI-00510 Helsinki, Finland  +358 10 394 11  Made in US  Rx Only    The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
Product number M1173310 containing lot numbers 12001 through 13031.
US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters
GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Southern California Permanente Medical Group Blood Donor Ctr
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, in which leukoreduced filtering was conducted beyond the allowable time limits, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, in which viral testing sample was exposed to unacceptable temperatures during storage, was distributed.
Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
Red Blood Cells Frozen Leukocytes Reduced Irradiated
Red Blood Cells Frozen Leukocytes Reduced
Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.
Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam Springs, AR (2) 9212 TRIENZA Bulk Capsules (SKU 91980) packaged in varying quantities in poly bags within corrugated containers.
54,887 bottles, and 327,139 bulk capsules
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Dietary Supplement packaged in the following configuration:  (1)Nutri-Essence Digestion Super Potency Enzymes & Herbs with patent-pending CereCalase Plus, packaged in 180-(SKU 51832) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO  (2) Positive Changes Hypnosis Centers Enzymes Digestion Dietary Supplement packaged in 60-(SKU 53793) and 180-(SKU 53794) capsule bottles. The firm name on the bottle is Positive Changes Hypnosis Center Dublin, OH 43017
ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO
Advanced Formula, CarbohydrEnz, packaged in 60-(SKU 52083) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO
3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814
Dietary Supplements packaged in the following configurations:  (1)Transformation Professional Protocol Digest Enzyme Supplement, Packaged in 45-(SKU 54646), 60-(SKU 52413), 90-(SKU 52520), 120-(SKU 53098) capsule bottles. The firm name on the label is Transformation Enzyme Corp. Houston, TX;  (2) 3989V TEC-TPP DIGEST UNL 60' unlabeled 60-(SKU 53571) capsule bottles;  (3) Transformation Digest. Packaged in 60-(SKU 54599) capsule bottles. Russian label;  (4) Anti-aging Nutrition Health Graph Professional Strength Digest Enzyme Supplement. Packaged in 120-(SKU 54752) bottles. The firm name on the label is Health Graph, Glenview, IL;  (5) The Lohad Center for Anti-Aging Digest Enzyme Supplement. Packaged in 90-(SKU 54914) capsules bottles. The firm name on the label is The Lohad Center, Jacksonville, FL.  (6) Bulk 3989V TPP-TEC Digest Conv Pa capsules (SKU 92494) packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
enzyme essentials, OxiCellZyme, Enzyme Supplement with Herbs, packaged in 90-(SKU 54929) and 180-(SKU 52270) capsule bottles.
WELLZYMES, Digestive Health, Enzyme Supplement  packaged in 60-(SKU 52235) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO
WELLZYMES, Gastric Ease, Enzyme Supplement  packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO
4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export.
Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ.
Dietary Supplements packaged in the following configurations:  (1) Houston Enzymes, No-Fenol, Multi-Enzyme Product for Digestion of Phenolic Foods and Fiber packaged in 90-capsule bottles (SKU 52437). Firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam, AR;  (2) 5327 Houston NO-FENOL blk 1v, Bulk Capsules (SKU 91456)
Dietary Supplement packaged in the following configurations:  (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027);  (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028);  (3) NWC Naturals Ultra Enzyme Support packaged in 200-(SKU 52466) and 90-(SKU 52467) count capsule bottles. Manufactured exclusively for Natural Wellness Centers of America, Laguna Hills, CA.
Dietary Supplement packaged in the following configurations:  (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (SKU 52587), 120-capsule bottles (SKU 52588), and 200-capsule bottles (SKU 53853). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;  (2) KIRKMAN, EnZym-Complete / DPP-IV, GF/CF Enzyme Dietary Supplement, packaged in 200-capsule bottles (SKU 54956). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;
NWC Naturals, Daily Cal, packaged in 200-capsule bottles (SKU 53343). Manufactured exclusively for Natural Wellness Centers of American, Inc. Laguna Hills, CA.;
WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO.
Dietary Supplement packaged in the following configurations:  (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.;  (2) 6306 WellZymes CarboDigest U, packaged in 90-capsule, unlabeled bottles (SKU 54799);
Dietary Supplement packaged in the following configurations:  (1) KIRKMAN Phenol Assist, packaged in 90-capsule bottles (SKU 52640). Manufactured exclusively for Kirkman, Lake Oswego, OR.;  (2) 6379 Kirk Phenol Assist UNL, packaged in 90-capsule unlabeled bottles (SKU 53855)
Dietary Supplements packaged in the following configurations:  (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN;  (2) 6895 Hlthy Alternatives Amyl, packaged in 90-capsule unlabeled bottles (SKU 54328)
Dietary Supplements packaged in the following configurations:  (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274);  (2) Bulk 6916 WEDAR DIGESTIVEBLEND powder, packaged in varying quantities in poly bags within fiber drums (SKU 82426);
Dietary Supplements packaged in the following configurations:  (1) 7 Lights, FULL SPECTRUM ENZYMES, packaged in 90 capsule bottles (SKU 52785). Firm name on the label is 7 Lights, Black Mountain, NC;  (2) 6926 Crusador TempleBuilders, packaged in unlabeled 90 capsule bottles (SKU 54335);
Dietary Supplements packaged in the following configurations:  (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939);  (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unlabeled 180-capsule bottles (SKU 53852);
Bulk 7775 GreenPlanet Enzymeblend Powder packaged in poly bags within fiber drums (SKU 82566)
8532 Kirkman MaxEnzComp w/DP packaged in unlabeled 120-capsule bottles (SKU 53854)
Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461)
Dietary Supplements packaged in the following configurations:  (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA;  (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled, 90-capsule bottles (SKU 54756);
Northern Nutrition, Pro-3-Zyme, packaged in 180-capsule bottles (SKU 53373). Firm name on the label is Northern Nutrition, LLC, Shipshewana, IN;
Bulk 9245 YOGIHOUSE DIGESTIVE BUL powder, packaged in poly bags within corrugated containers (SKU 82993);
9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666);
Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033);
Bulk 9414 PROTHERA CANDIDACHLOREL powder, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83056);
Bulk 9665 BioSan Labs Hi Potency capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92093);
DigestEasy, Hypoallergenic Enzyme Supplement, packaged in 60-capsule bottles (SKU 53557). Firm name on the label is Master The Body, Joliet, IL
Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085).
Bulk 9843 NOW Digest Platinum BLK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92101).
Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).
Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131).
NWC Naturals, Total-Nutrition Program, Dietary Supplement with L.E.A.D.S., packaged 270-capsule bottles (SKU 92131). Firm name on the label is Natural Wellness Centers of America, Inc., Laguna Hills, CA;
Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A164 NUTRACHOICE DIGESTIVEBL powder (SKU 83196), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Dietary Supplement Formula ID A200;  Packaged in the following configuration: Bulk A200 Nutr Provider Comp Dige capsules (SKU 92132), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A322 Houston Chewable Enzyme powder (SKU 83226), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO;
Bulk A776 Healthline Nutri Pet Di powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83287);
Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318);
Bulk A977 Wedar Digestive Blend 2 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83314);
Dietary Supplements packaged in the following configuration:  (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA;  (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC;  (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54555). Firm name on the bottle is National Enzyme Company, Forsyth, MO;  (4) Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54784). Firm name on the bottle is Natural Solutions 101, Walnut Shade, MO;  (5) NEC, Healthy Digest, Full Spectrum Digestion, packaged in 90-capsule bottles (SKU 54169). Firm name on the label is National Enzyme Company, Forsyth, MO;  (6) Solutions Rx, DIGESTIVE WELLNESS, COMPLETE DIGESTIVE ENZYME FORMULA, packaged in 90-capsule bottles (SKU 54608). Firm name on the bottle is Pharmacy & Healthcare Solutions, Saltillo, MS;  (7) The Essentials, Ultra Professional, Digestive Essentials, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54512). Firm name on the label is Ask The Pharmacist, Oakmont, PA;  (8) FeelIt Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54872). Firm name on the label is Victory International Group, Irvine, CA;
Dietary Supplements packaged in the following configuration:  (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO;  (2) Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women  packaged in 60-capsule bottles (SKU 54632). Firm name on the label is Root 86, Ridgedale, MO;
Bulk B199 Reviva Digestion Bulk powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83342).
Dietary Supplements packaged in the following configurations:  (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275);  (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA.
TriEnza Powder with DPP IV Activity, packaged 105 gram bottles (SKU 54045). Firm name on the label is Houston Nutraceuticals, Inc., (HNI), Siloam Springs, AR;
Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);
Dietary Supplement Formula ID B859;  Packaged in the following configuration:   B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112);
Bulk B910 Houston Nutr TriEnz Bu powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83381);
B911 Kirkman Max Spectrum E, packaged unlabeled, 90-capsule bottles (SKU 54255);
Bulk B983 Vitamin Shoppe Advnaced powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83408);
IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT;
IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT;
Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92438);
Bulk C184 Ace Health Enzyme Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83403);
Multi Plant Enzyme Tablets, packaged 60 tablet bottles(SKU 54451). Firm name on the label is Wedar Nutrasource Inc., Hacienda Height, CA;
Dietary Supplements packaged in the following configurations:  (1) Heryben, Eumin Integrated Plant Enzymes, packaged 60 capsule bottles(SKU 54440). Firm name on the label is ActiFit Biotechnology, Bellevue, WA;  (2) Bulk C269 Shanghai Digestive Blen capsules, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92473);
Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419);
Enzyme - Travnie Extra, Formula C500, packaged in 30-capsule bottles (SKU 54513). Firm name on the label is National Enzyme Company;
Bulk C542 Vitakost Low Carb Diet, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92544);
Dietary Supplements packaged in the following configurations:  (1) Carbo Converter-I powder, packaged 25 gram bottles (SKU 54663). Firm name on the label is National Enzyme Company, Forsyth, MO;  (2) C560 NEC Carb Converter Blen packaged in unlabeled, 25 gram bottles.
Cellulase Cellulolytic Enzymes, packaged 100-capsule bottles (SKU 54553). Firm name on the label is Healthy Reflections, Garfield, MN;
Healthy Reflections, Colon Health Support, packaged 120-capsule bottles (SKU 54554). Firm name on the label is Healthy Reflections, Garfield, MN;
Dietary Supplements packaged in the following configurations:  (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR;  (2) Bulk C613 Houston No-Fenol Bulk powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83451);  (3) Bulk C613 Houston No-Fenol Chew T chewable tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92566);
594 bottles, 0.23 kg of powder, and 20,580 bulk capsules
Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000)
Bulk C676 BnG Global Digestive Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83430)
Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438)
PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label;
Healthy Alternatives, Digestion & Stomach Upset Support, packaged 90-capsule bottles (SKU 54897). Firm name on the label is Health Enhancement, Inc. Grass Valley, CA;
Bulk D008 Glykon Tech Digestive B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83453)
Bulk D103 Life Tree Digestive Ble powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83466).
Dietary Supplements packaged in the following configurations:  (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453);  (2) Bulk Bision Isolase powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72073);  (3) Bulk Isolase (Shanghai) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72077);  (4) Bulk Isolase (Wedar) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72080);  (5) Bulk Isolase (Nutri Sport) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72106);
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Tres Leches, Lymar, Peso Neto 3 oz, Ponce, Puerto Rico
Undeclared allergens: eggs, wheat and soy
PedFuse Reset Screw; Model: 01-80115-55   The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
SIG CAFE ITALIAN PASTA SALAD KIT, 216325, NET WT 5.68 LBS, Distributed by Lucerne Foods, Inc.,  PO Box 99, Pleasanton, CA  94566-0009, 877-232-4271
The firm manufactured and distributed one salad kit which contained salad dressing supplied by Reser's which was recalled due to possible Listeria monocytogenes contamination.
AL, FL, TN, LA, KY, NC, OH, GA, MI, SC, MO
Broccoli Crunch Kit 1 cnt, 432714, 59520, TAYLOR FARMS TN, SMYRNA, TN  37167
The firm manufactured and distributed 6 salad kits which contained salad dressing supplied by Reser's which was recalled due to possible Listeria Monocytogenes contamination.
Broccoli Crunch Kit 2 cnt w/ red Onion 10030223091285, 592500, TAYLOR FARMS TN, SMYRNA, TN  37167
Broccoli Crunch Kit PP 92051229, SAFEWAY ITEM#, 1/7#, 59001, DISTRIBUTED BY LUCERNE FOODS, INC, PO BOX 99, PLEASANTON, CA 94566-0009, 1-877-232-4271
Broccoli Slaw Kit, 1/6.5#, 85004, TAYLOR FARMS TN, SMYRNA, TN  37167
Giardiniera Vegetable Salad Kit 1cnt, 1/13#, 59431, TAYLOR FARMS TN, SMYRNA, TN  37167
Spinach Antipasti Salad Kit 1cnt, 438405, 1/8#, 59433, TAYLOR FARMS TN, SMYRNA, TN  37167
74 -  14 oz cups 16 -   5lb bags  75 -  10lb cs (2-5lb bags/cs)
LIPARI OLDTYME Mexicali Dip, Keep Refrigerated, outer box Net Wt. 1 0 lbs. Distributed by Lipari Foods, Warren, Ml 48089 Inner container:  Mexicali Dip, Dutch Treat Salads, Zeeland MI Net Wt. 5 Lbs.  Mexicali Dip, Dutch Treat Salads, Zeeland , MI Net Wt 14 oz. 396.9 g  Ingredients: INGREDIENTS CULTURED SOUR CREAM (PASTURIZED  HOMOGENIZED MILK, CREAM, MODIFIED FOOD STARCH, NONFAT  DRIED MILK, SODIUM PHOSPHATE, GUAR GUM, SODIUM NITRATE,  POTASSIUM SORBATE, CARRAGEENAN, lOCUST BEAN GUM,  ACTIVE CULTURE), BLACK( BEAN SALSA (TOMATOES, BLACK  BEANS, WATER, CORN, TOMATO PASTE, RED Bell PEPPER,  JALAPENO PEPPER, VINEGAR, SEASONING, Salt, SUG AR, SPICES,  DEHYDRATED GARLIC, CILANTRO CONCENT, XA NTHAN GUM,  POTASSIUM SORBATE, SODIUM BENZOATE,  DRIED  CHIVES), CHEDDAR CHEESE, MAYONNAISE (VGETABLE OIL  [SOYBEAN AND CANOlLA OILS], EGG YOLK, WATER CORN SYRUP,  VINIEGAR. SALT. SPICES. CALCIUM DISODIUM E'DTA) S'EASONING  MIX. CHILl POWDER. POTASSIUM SOHBATE  CONTAINS: EGG. MILK, SOY
Use By dates of 10/18/13 through 11/22/13.
Product has  potential Listeria monocytogenes contamination.
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003  Revisions: 0, 1, 2      Product Usage:  A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661  Assembled at : MEDICA 41036 Medolla, Italy  Filters are packaged in a Tyvek pouch and then placed inside a cardboard box.  15 filters per box    The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
Item Number 70-023 and 70-0238 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236  2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237    Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661    Assembled at MEDICA 41036 Medolla, Italy     The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose
Item Number 70-0236 and 70-0237 all lots Document number 60-0237, 60-3004 and 60-3005 - all documents
3472 SS units; 513 FH units; 1219 HH units
Blood product, which may have been exposed to unacceptable temperature during storage, was distributed.
Blood product, with a low platelet count, was distributed.
Blood product, which may have been exposed to unacceptable temperatures during storage, was distributed
Product was shipped to the following states: GA, IL, IN, MI & TN.
Bremer Garlic Shrimp MEAL IN MINUTES Pasta in Garlic Sauce with Broccoli, Shrimp, Corn and Carrots 21 oz bags, CONTAINS: WHEAT, MILK, CRUSTACEAN SHELLFISH (SHRIMP) Distributed by ALDI Inc., Batavia, IL 60510 0 41498-17223-7 3-cheese chicken & Chicken Lo Mein was recalled by USDA.
The firm discovered a potential for undeclared egg in their Bremer Garlic Shrimp skillet meal.
UT-Fem FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc.
The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb.  The supplier, Specialty Enzymes & Biotechnologies, recalled the raw materials and notified the recipients.  Subsequent private laboratory testing of the finished product revealed levels of chloramphenicol above 0.3 ppb.
(a) ONEBODE Flo daily, probiotic enzyme digestive, 90 capsules, dietary supplement, Product No. T00135, UPC 0 14834 00135 5; (b) ONEBODE Flo for Family, probiotic enzyme digestive, 360 capsules, dietary supplement, Product No. T00109, UPC 0 14834 00109 6; (c) ONEBODE Flo daily, probiotic enzyme digestive, 6 capsules, dietary supplement (SAMPLE PACK), Product No. T00111, UPC 0 14834 00111 9 --- Mfg. for OneBode, Chandler, Arizona 85226
Lot 1262057: 1985 bottles; Lot 1262058: 489 bottles;  Sample packs: 11,276 units
The finished dietary supplement product was manufactured with ingredients found to be contaminated with chloramphenicol, an antibiotic, above levels of 0.3 ppb.
Blood products, not prepared in accordance with specifications, were distributed.
Lifesouth Community Blood Centers - Montgomery Region
Blood products, with a low platelet count, were distributed.
Joliet Blood Plasma LLC dba Plasma Care, Inc.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed
Lam Sheng Kee HAW FLAKES, NET WEIGHT 380 g (13.4 oz), product is packaged in plastic bag with twenty four (24) bags per carton.  UPC 6 949682 803780.  Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED, RM3/8F., YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI, HK. Distributed by: WIN LUCK TRADING INC 100 Pulaski Street Bayonne, NJ 07002. Product of China.
A&C US Trading LLC., has recalled Haw Flakes due to use of unapproved food coloring.
919,616.31 total pounds, for all products
Garden-Fresh Foods is recalling various cut vegetables,  ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013  because they may be contaminated with Listeria monocytogenes.
Garden-Fresh Foods is recalling various cut vegetables, ready-to-eat salads, slaw, spread and dip products sold under various brands and code dates manufactured prior to November 06, 2013 because they may be contaminated with Listeria monocytogenes.
Garden-Fresh,  Amish Country Mustard Potato Salad, 2/5 lb.,  0 11596 51015 6 11/22/2013 - 12/9/2013
Finest Traditions, Black Olive Jalapeno Pepper Spread, 2/4 lb., 10 733147 10859 5, 11/25/2013
Finest Traditions, Broccoli Cauliflower Salad Base, 5/2.125 lb. , 10 733147 10647 8, 11/20/2013 - 12/9/2013
Garden-Fresh, Cabbage Chopped with Red Cabbage, 4/5 lb. , 0 11596 50119 2,    10/31/2013
Finest Traditions, Cheddar & Bacon Potato Filling, 1/8 lb. , 10 733147 10262 3 11/11/2013 - 11/18/2013
Finest Traditions, Cheddar Cheese & Olive Spread,  2/4 lb., 10 733147 10860 1, 11/25/2013
Garden-Fresh, Cheese Tortellini Salad Toscana,  1/5 lb.,  0 11596 52075 9,  11/2/2013 - 12/10/2013
Garden-Fresh, Chopped Broccoli / Cauliflower Salad Base, 1/5 lb., 0 11596 55188 3, 11/27/2013 - 12/5/2013
Garden-Fresh, Country Potato Salad, 2/5 lb. ,0 11596 51075 0, 12/5/2013
Garden-Fresh, Cranberry Apple Relish, 1/5 lb.,  0 11596 17092 3, 12/16/2013
Finest Traditions, Creamy Cheddar Macaroni Salad, 1/8 lb.,  10 733147 10156 5, 11/20/2013 - 12/9/2013
Garden-Fresh European Style Chocolate Mousse 1/5 lb.  0 11596 55085 5 11/16/2013 - 12/5/2013
Garden-Fresh, Fat Free Broccoli with Rigatoni Salad, 2/4 lb.,  0 11596 52064 3, 11/9/2013
Finest Traditions, Fresh Salsa Spicy, 6/11 oz., 10 733147 10996 7, 12/9/2013
Finest Traditions, Garden Vegetable Spaghetti Salad, 1/8 lb.,  10 733147 10196 1, 11/25/2013 - 12/9/2013 ;
Dairy Fresh, Homemade Dixie Cole Slaw,2/5 lb., 0 70163 55890 8, 12/8/2013;
Dairy Fresh, Homemade Macaroni Salad, 2/5 lb., 0 70163 89080 0 12/8/2013; ;
Dairy Fresh, Homemade Mustard Potato Salad, 2/5 lb.,  0 70163 56700 9, 12/10/2013;
Dairy Fresh, Homemade Potato Salad, 2/5 lb.,  0 70163 56575 3, 12/6/2013;
Garden-Fresh, LCR Lettuce Tossed / Garni Bags, 4/5 lb.,  0 11596 50150 5  ,11/4/2013
Dairy Fresh, Mexicalli Taco Pasta, 1/5 lb.,  0 70163 55999 8,12/10/2013
Finest Traditions, Mint Chocolate Chip Cookie Mousse, 1/5 lb.,  10 733147 11017 8, 11/20/2013 - 12/9/2013; Garden-Fresh, Mint Chocolate Chip Cookie Mousse, 1/5 lb.,  0 11596 55069 5, 11/22/2013 - 12/9/2013;
Garden-Fresh, Parmesan Peppercorn Pasta Salad Base, 1/5 lb.,,  0 11596 52086 5, 11/20/2013 - 12/1/2013;
Garden-Fresh, Peeled & Sliced Cucumbers, 1/7 lb.,  0 11596 70582 8,                         11/11/2013;
Finest Traditions, Penne Pasta with Roma Tomatoes, 1/8 lb.,  10 733147 10286 9, 11/25/2013 - 12/9/2013;
Spoon River, Pimento Cheese Spread, 1/5 lb.,  0 11596 55678 9, 12/23/2013;
Garden-Fresh, Quinoa Natural Energy Salad, 1/8 lb.,  0 11596 82074 3, 12/2/2013;
Garden-Fresh, Seafood Salad Rouille, 1/5 lb.,  0 11596 55187 6, 12/6/2013;
Rogge's, Sliced Extra Sweet Potato Salad, 2/5 lb.,  0 11596 51054 5, 11/27/2013;
Finest Traditions, Sour Cream & Chive Potato Filling, 1/8 lb,  10 733147 10261 6, 11/11/2013 - 11/18/2013;
Copperwood Kitchens, Steakhouse Macaroni Salad, 2/5 lb.,  8 11839 01018 0, 12/5/2013
Finest Traditions, Strawberry Yogurt Cheesecake Dessert, 1/5 lb.,  10 733147 11018 5, 11/20/2013 - 12/9/2013; Garden-Fresh, Strawberry Yogurt Cheesecake Dessert, 1/5 lb.,  0 11 11596 55028 8 11/25/2013 - 12/7/2013;  Old Tyme, Strawberry Yogurt Cheesecake Dessert, 1/5 lb.,  0 94776 03303 4, 11/26/2013 - 11/29/2013  ;
Garden-Fresh, Whole Grain Penne with Spinach, Tomato & Feta, 1/5 lb,.  0 11596 52063 6, 11/26/2013 - 12/6/2013;
Garden-Fresh, Whole Wheat Pasta with Sun Dried Tomatoes, 1/5 lb.,  0 11596 52094 0, 11/30/2013 -12/14/2013;
10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.
Lack of Assurance of Sterility; Drug product leaking from container, therefore sterility cannot be assured
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA.  Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone  Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D  Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer.
Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
Worldwide Distribution - USA (nationwide) and the countries of  Aruba, Canada, Colombia and Trinidad.
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA   daily use disposable contact lenses
Lot 361950571720, potential incorrect expiry date 1/2018;  Lot 361950575934, potential incorrect expiry date 9/2017;   Lot 361950589008, potential incorrect expiry date 2/2018;   Lot 361950590915, potential incorrect expiry date 8/2018;  Lot 361950597210, potential incorrect expiry date 7/2017;  Lot 361950599011, potential incorrect expiry date 8/2018;  Lot 361950599816, potential incorrect expiry date 9/2017;  Lot 361950606714, potential incorrect expiry date 12/2017;   Lot 361950608721, potential incorrect expiry date 6/2018;   Lot 361950613813, potential incorrect expiry date 1/2018;  Lot 361950632507, potential incorrect expiry date 3/2018;  Lot 361950638202, potential incorrect expiry date 2/2017;  Lot 361950644719, potential incorrect expiry date 10/2018;  Lot 361950646326, potential incorrect expiry date 10/2018;  Lot 361950647128, potential incorrect expiry date 10/2018;   Lot 361950676608, potential incorrect expiry date 12/2018;  Lot 361950682615, potential incorrect expiry date 10/2017;  Lot 361950684220, potential incorrect expiry date 10/2019;  Lot 361950691505, potential incorrect expiry date 1/2017;  Lot 361950692806, potential incorrect expiry date 7/2018;  Lot 361950706108, potential incorrect expiry date 12/2018;  Lot 361950706308, potential incorrect expiry date 1/2015;  Lot 361950711903, potential incorrect expiry date 7/2018;  Lot 361950712707, potential incorrect expiry date 2/2017;  Lot 361950742714, potential incorrect expiry date 1/2017;  Lot 361950744516, potential incorrect expiry date 10/2017;  Lot 361950767118, potential incorrect expiry date 4/2018;  Lot 361950778620, potential incorrect expiry date 1/2018;  Lot 361950789608, potential incorrect expiry date 4/2018;  Lot 361950800811, potential incorrect expiry date 3/2017;  Lot 361950826215, potential incorrect expiry date 3/2018;  Lot 361950829333, potential incorrect expiry date 9/2017;  Lot 361950839008, potential incorrect expiry date 4/2017;  Lot 361950845916, potential incorrect expiry date 3/2018;  Lot 361950859017, potenti
Lots were labeled with incorrect expiration dates on secondary package (carton).  The primary package (blister) is marked with the correct expiration date.
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA   daily use disposable contact lenses for astigmatism
Lot 446350083516, potential incorrect expiry date 6/2019; Lot 446450110928, potential incorrect expiry date 2/2019;  Lot 446450173709, potential incorrect expiry date 4/2018;  Lot 446450191100, potential incorrect expiry date 5/2019;  Lot 446550083005, potential incorrect expiry date 5/2019;  Lot 446550084607, potential incorrect expiry date 2/2018;   Lot 446650162408, potential incorrect expiry date 2/2018;  Lot 446650177200, potential incorrect expiry date 2/2018;  Lot 446650178110, potential incorrect expiry date 6/2017;  Lot 446650179207, potential incorrect expiry date 6/2018;  Lot 446750082713, potential incorrect expiry date 7/2019;  Lot 446850029326, potential incorrect expiry date 4/2016;  Lot 446850032905, potential incorrect expiry date 4/2016;  Lot 446850129305, potential incorrect expiry date 1/2019;  Lot 446850132713, potential incorrect expiry date 3/2019;  Lot 446850133506, potential incorrect expiry date 6/2018;  Lot 447050177419, potential incorrect expiry date 2/2018;   Lot 447050181906, potential incorrect expiry date 1/2017;   Lot 447050206016, potential incorrect expiry date 11/2019.
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198)   Product Usage:  The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.
Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2.   '' Transoral intubation '' Transnasal intubation '' Evaluation of placement of endotracheal and double lumen endotracheal tubes '' Provide visual access to the larynx and tracheobronchial tree.
KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was thermoplastic polyurethane (TPU), which is not listed in STERRAD systems claims for interior endoscope lumens.
Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1.   '' Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy '' Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias '' Uncontrolled hypertension '' Bleeding disorder or use of anticoagulants.
AZ, KY, IA, MO, NY, OH, PA, TN, TX, UT, VT
DRUK Orange Squash Contains 25% Orange Juice Net Wt. 24 fl oz.    Imported by:  Balajee Trade Link, LLC  Scranton, PA USA  Product of Bhutan
Sample analysis by FDA found the product to contain undeclared sunset yellow FCF
DRUK Mango Squash Contains 25% Orange Juice Net Wt. 24 fl oz.    Imported by:  Balajee Trade Link, LLC  Scranton, PA USA  Product of Bhutan
Sample analysis FDA found the Mango Squash to contain undeclared tartrazine (FD & C Yellow #5) and sunset yellow FCF (FD & C Yellow #6)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
USA Nationwide Distribution and one foreign consignee in Mursalat.
Integra Disposable, Convenience Kit  Single Shot Epidural Tray  Reorder Number 340269 Rx Only   Product Usage:  The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Australia, Austria, Belgium, Denmark, Egypt, Finland, France, Germany, Jamaica, Ireland, Israel, United Kingdom, Luxembourg, Netherlands, Norway, Sweden, Switzerland, UAE, and Canada.   **Center Recommended Depth - Consumers/User**
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing.  50 count  UPC 6 99073 12050 2;  Freestyle Blood Glucose Test Strips; for Institutional Use only  50 count:  UPC  6 99073 70792 5    Manufactured by Abbott Diabetes Care Inc. Alameda, CA.    The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Part number 12050-21: Lot number: 1285007 Exp. date: 2014/06;  Part number 70792-20 (instuitional use)  Lot number: 1373262, Exp. Date 2015/02
141,219 cartons for human use - all lot numbers
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood  Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood  glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing.  50 count; 100 count Product  of Ireland;    UPC 6 99073 70819 9; - 50 count  UPC 6 99073 70822 9 - 50 count  UPC 6 99073 71026 0 - 50 count  UPC  6 99073 70827 4 - 100 count    Manufactured by Abbott Diabetes Care Inc. Alameda, CA.    The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.
Grove Grow Notes Fruit of Wolfberry (Fructus Lycii) Net Wt: 12 oz (340g) S & M (USA) Enterprise 4703 2nd Avenue Brooklyn, NY 11232 UPC 4580158101515    S & M (HK) Enterprise Ltd Rm, 3.8/F., Yue Xiu Bldg., 160-174Lockhart Road, Wan Chai, HK   Product of China
NYSDAM Sampling results has revealed the presence of undeclared sulfites in Fruit of Wolfberry.
Worldwide Distribution - USa (nationwide) and Internationally to: Austria, Belgium, Czech Rep, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia and Japan
Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Products were shipped labeled with ''use by'' dates that exceed currently available shelf-life data.  All products remain within the earliest expiration date of April 2015.
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA    Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M0031681910; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number:  M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand GDC-18 360 18MM X 30CM, Catalog Number:  M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by  Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand COMPLIANT 5MM X 15MM, Catalog Number:  M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA       Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand COMPLIANT 5MM X 30MM, Catalog Number:  M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number:  M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number:  M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA   Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature. GDC 10, 18 Coils: The Gugliemi Detachable Coil is intended for the endovascular embolization of: (1) Intracranial aneurysms, (2) Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistula, (3) Arterial and venous embolizations in the peripheral vasculature GDC 18-Fibered VortX Shape Coil: The GDC 18-Fibered VortX Shape Coil is intended for embolization of vascular abnormalities such as (1) Arteriovenous malformations and arteriovenous fistulae of the neurovasculature; (2) GDC 18- Fibered VoliX Shape Coil is also intended for arterial and venous embolizations in the peripheral vasculature. Transform: The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Aunt Jemima(R) HOMESTYLE FRENCH TOAST, 6 COUNT, NET WT. 12.5 OZ (354 g), UPC Code: 019600057703
This French Toast product contains bread (as an ingredient) that the supplier (Lewis Brothers Baking) is recalling because the bread has the potential for containing stainless steel fragments from a damaged dough mixer.
Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.
Mega Needle Driver, 8MM assembly of the da Vinci S  IS1200 and da Vinci Si,  IS2000.   Manufactured by Intuitive Surgical, Sunnyvale, CA.    EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Large Needle Driver, 8MM assembly of the da Vinci S  IS1200 and da Vinci Si,  IS2000.   Manufactured by Intuitive Surgical, Sunnyvale, CA.    EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Carbon Dioxide, USP, Medical Gas, Rx only, Non Flammable Gas 2, in 50 lbs steel cylinders, Distributed by AIRGAS USA, LLC Radnor, PA
NDC 11054-002 Lot # TY00A260A Size G and H        Part number 835148
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
Products were distributed in Southern California, Virginia, Maryland, District of Columbia, Delaware, Pennsylvania, New Jersey, Ohio, and Kentucky.
Chocolate Cream Pie, 4.5 oz. package, 12 pks/case. UPC # 891796002732
Chocolate pie contains almonds which are not declared on the label.
Worldwide Distribution - USA (nationwide) and the countries of  Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Mexico, United Arab and Emirates.
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth.   Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.
Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.
Source Naturals Essential Enzyme Ultra VEGI-CAP: Premium Digestive Enzyme Blend;  30, 60, 90 & 120 count bottles.   Vegetarian capsules    Manufactured for:  Source Naturals, Inc.  Santa Cruz, CA
Dietary Supplements were made with bulk products provided by National Enzyme Company which are currently under recall for chloramphenicol
US: AK, AL, AR, AZ, CA, CI, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NS, NT, NC, ND, NE, NH, NJ, NM, NV, NY, H, OK, OR, PA, PR, RI,SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.   OUS: South Korea, Ghana, Romania and Singapore.
Nature's Way, UPC 33674149263, Alive Whole Food Energizer with Iron, 60 Tabs 20009807;    Nature's Way, UPC 33674149270, Alive Whole Food Energizer with Iron, 90 Tabs 20009808.    33674149287  Alive Whole Food Energizer with Iron, 180 Tabs 20012063
Nature's Way (NW) is voluntary recalling a number of products because the raw material supplier informed them that enzymes in the blend they provided to NW may contain the antibiotic chloramphenicol.
Nature's Way,UPC 33674149324 Alive Whole Food Energizer ,180 Tabs, 20009819, 20012443
Nature's Way,UPC 33674150900, Alive Whole Food Energizer MultiVitamin 90 Vcaps,  20009817
Nature's Way,UPC 33674150924, Alive Whole Food Energizer MultiVitamin ( No Iron Added), 90 Vcaps,  20009818
Nature's Way,UPC 33674155424, Alive Whole Food Energizer Men's, 90 Tabs, 20010871
Nature's Way,UPC 33674156797, Alive Once Daily MultiVitamin Ultra Potency, 60 Tabs,  20008123,  20010552
Nature's Way,UPC 33674156858, Alive Once Daily Men's Ultra Potency, 60 Tabs, 20010553,  20012800
Nature's Way,UPC 33674156865, Alive Once Daily Women's Ultra Potency, 60 Tabs,  20010554,  20011595,  20014135
GL Completia, 90 vcaps HDPE Bottle in a Box 12
Alive No Iron  (for international sales), 30 Tabs HDPE Bottle in a Box 12
Distributed in the following states: FL, GA, IL, IN, KY, MD, MI, NC, NJ, NV, NY, OH, PA, and SC.
Flora Double Ginger Herbal Tea Blend, 16/1.24 oz (35.2g) tea bags per package.  UPC 0 61998 63757 9   The product is labeled in parts: ''***DOUBLE GINGER HERBAL TEA BLEND***FLORA***CERTIFIED ORGANIC***FRESH-SEALED TEA BAGS***16***NET WT 1.24 oz***(35.2 g)***INGREDIENTS: GINGER ROOT, LEMONGRASS HERB, PEPPERMINT LEAVES, LICORICE ROOT, BLACK PEPPER SEEDS, *ORGANIC***IMPORTED BY: FLORA INC., 805 E. BADGER RD. LYNDEN, WA***''.
BB/MA: 2019-09,  LOT: 13268 10314 19R8F 268:17:49   Give a breakdown of the code:    BB/MA = Best before date 2016-09;  LOT 1326810314;  19RF = Organic number  268:17:49 = Manufacturing date and time
Flora Double Ginger Herbal Tea Blend 1.24 oz was recalled due to contamination with Salmonella.
US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.
MagNA Pure 96 System Version 1.0  Software Version 2.0    Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.
This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification.  There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overview of the Pipetting Report (generated right after import of the xml file). If this issue has occurred, the corresponding Purification Report shows samples in a transposed order. However, the assigned sample information in the Purification Report (e.g., sample numbering, sample names, notes, position, and status) is correct; only the indicated sequence is wrong. This issue is not reproducible and only occurs randomly. To avoid a potential sample mismatch, discontinue use of the Pipetting Report to identify samples when manually pipetting samples after extraction.  MagNA Pure processes that generate a sample list xml file for downstream applications are not affected as they do not use the Pipetting Report.  The MagNA Pure 96 Instrument Operators Guide is being updated with an addendum addressing  this issue.
outer box: Ref 906768,  CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx  inner incorrect label:  CurvTek  7 MM Medium, Single Pack Quantity -3, REF 906760   To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly  PN: 906760 7mm Medium.
All product in USA is under Biomet control;  Europe, Italy, UK, Australia, Japan
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.
Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.
SEAC Advanced Dental System, Model A591561   The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
Trader Joe's stores in Southern California, Utah, Southern Nevada and Texas.
Trader Joe's Butternut Squash & Creamed Spinach Gratin, 16 oz.
One specific lot of Trader Joe's Butternut Squash & Creamed Spinach Gratin due to undeclared wheat and egg.
Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.
Medfusion 4000 Syringe Infusion Pumps   Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
All Medfusion 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.
Smiths Medical is conducting a recall involving  all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC power receptacle. The pump and the AC power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. Smiths Medical has received no reports of injury or any damage beyond damage to the pump and AC power cord associated with this issue. If this issue occurs there is a potential for a delay in therapy while a replacement or alternative method of delivery is obtained.
ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include:  non-TPN volumes administered to patients on TPN therapy in order calculations;  CVVH calculations;  Cardioplegia (Buckburg) calculations;  Epidural calculations;  Dilutions from concentrated ingredient;  Combinations of multiple ingredients; Fractional doses from larger volumes
Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.
InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus
GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets.  Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Nationwide. No military/govt/VA or foreign consignees.
Senor Murphy Santa Fe Candymaker Pecan Bueno, 4oz and 1 lb.  Handmade with pecans, sugar, corn syrup, butter, soda, and salt.
Senor Murphy Candymaker is recalling Pecan Bueno, Cashew Crunch, Chile Pistachio Bark, Chocolate Pretzels, Chile Peanuts, Pinon Brittle, Peanut Brittle, and Chile Peanut Brittle due to undeclared allergens.
Senor Murphy Santa Fe Candymaker Cashew Crunch , 4oz and 1 lb.  Handmade with cashews, sugar, corn syrup, butter, soda, and salt.
Senor Murphy Santa Fe Candymaker Chile Pistachio Bark  , 2.5 oz and 1 lb.  Handmade with dark chocolate (sugar, chocolate liquor processed with alkali, cocoa butter, milk fat, soy lecithin - an emulsifier, natural flavors), pistachios, chile, salt.
Senor Murphy Santa Fe Candymaker Chocolate Pretzels 3 oz.
Senor Murphy Santa Fe Candymaker Chile Peanuts, 4 and 9 oz. Handmade with peanuts, sugar, corn syrup, brown sugar, butter, baking soda, Shimayo red chile, and salt.
Senor Murphy Santa Fe Candymaker Pinon Brittle , 4 oz and 1 lb. Handmade with pinones (pine nuts), sugar, corn syrup, butter, soda, and salt.
Senor Murphy Santa Fe Candymaker Peanut Brittle , 4 oz and 1 lb.
Senor Murphy Santa Fe Candymaker Chili Peanut Brittle , 4 oz and 1 lb. Handmade with sugar, corn syrup, peanuts, butter, soda, chile, and salt.
Nationwide, Puerto Rico, Canada, New Zealand
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11
Failed Impurities/Degradation specifications: out-of-specification results at the 14 & 15 month time point