All products were sold to distributors located within the U.S. (CA, TX, AZ, NV, OR, NY, IL).  Distributors sells these products to food service facilities.  Some of these food service facilities provide food for airlines.  The firm confirmed that none of the products were sold as retail packs/sold as is directly to consumers.
Cambridge House Balmoral  Thinly Sliced Exceptional Ready to Enjoy  Smoked Salmon  Keep Refrigerated at 38 or below  Ingredients  Atlantic Salmon, Salt, Sugar, and Oakwood Smoke  Produced By:  The Santa Barbara Smokehouse  312 N. Nopal  Santa Barbara, CA 93103  www.sbsmokehouse.com    Coastal Harbor  by The Santa Barbara Smokehouse  Smoked Atlantic Salmon  Keep Refrigerated at 38 or below  Ingredients  Atlantic Salmon, Salt, Sugar, and Oakwood Smoke  Produced By:  The Santa Barbara Smokehouse  312 N. Nopal  Santa Barbara, CA 93103  www.sbsmokehouse.com    Products are distributed either refrigerated or frozen.  All products are packaged in reduced oxygen packaging (ROP).  Net weight appears to vary per package.  Products are priced per weight.
Batch Numbers: 8589 and 6549 6549  August 18 2014 Use By 09-16-14  8589  September 18/19 2014 Use By 09-15-15     Products that are frozen have a more extended shelf-life/use by date.
The firm was notified by two customers of two lot/batch numbers testing positive for Listeria monocytogenes which is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.  Listeria infection can also cause miscarriages and stillbirths among pregnant women.
Blood products, collected from a donor who tested reactive for anti-HBc on two separate occasions, were distributed.
Product was distributed in the following states:  TX, MA, ME, CT, CA, NH, NY, TX, NJ
Aleia's Parmesan Croutons, Gluten Free, NET WT 8 oz (226.8g).  UPC Code:  8 55930 00162 3, Product is packaged in a brown cardboard box with white text.
Product manufactured with cumin that may contain peanut protein.
Aleia's Classic Croutons, Gluten Free, NET WT 8 oz (226.8g).  UPC Code:  8 55930 00161 6, Product is packaged in a brown cardboard box with white text.
CT, DC, KY, MA, MD, ME, NH, NJ, NY, OH, PA, RI, VA
Guacamole Dip Net Wt. 8 OZ. (.5LB) Distributed By: Whole Foods Market UPC/PLU: 0-36406-30279-0; WFM Dip Guacamole PPK UPC/PLU: 3640630278; Guacamole Bulk CC UPC/PLU: 27013500000 in plastic container
All Sell by dates through 2/10/15; Bulk product Sold from food bars thru 2/5
Undeclared peanut protein in products containing cumin
Slaw Kale Avocado HSH 14 oz. UPC/PLU code: 0-00000-68899
Tofu Grilled Lime Chipotle UPC/PLU code: 2-31090-00000
Burrito Chipotle Lime Tofu UPC/PLU: 2-65293-00000; Burrito Chipotle Lime Tofu Tacos UPC/PLU: 2-83938-00000
Taco Salad Tofu Chipotle Lime UPC/PLU: 2-65294-00000
Salsa Fresca Net Wt. 8 oz. (.5LB) Whole Foods Market; WFM Salsa Fresca PPK; UPC/PLU: 3640630306; Salsa Fresca Bulk CC UPC/PLU: 26206400000
All Sell by dates through 2/10/15; bulk products: Sold from food bars thru 2/5
Pico De Gallo Salsa Net Wt. 8 oz. (.5LB); WFM Dip Salsa Pico De Gallo PPK UPC/PLU: 3640630279; Salsa Pico de Gallo Bulk UPC/PLU: 26890500000
All Sell by dates through 2/10/15; bulk: Sold from food bars thru 2/5
Adobo Enchiladas & Dirty Rice Net Wt. 48 OZ. (3LB) (1.36kg) Whole Foods Market Kitchens UPC/PLU: 036406302561; Enchilada Adobo Bulk UPC/PLU: 26978700000
Mediterranean Mezze Snack Pack Net Wt. 9.5 OZ (268g)  Whole Foods Market Kitchens UPC/PLU 036406304329
Whole Foods Market Vegetarian Firehouse Chili Net Wt. 24 oz. (1.5LB/680g) Whole Foods Market Kitchens UPC/PLU: 036406303940
Quesadilla Mushroom Goat Cheese UPC/PLU: 26405800000
Burrito Black Bean and Cheese UPC/PLU: 26270400000
Rub Latin Spice 5 LB. UPC/PLU: 48000006317
Marinade Lime Chipotle 2 Gallon UPC/PLU: 48000024264; Marinade Lime Chipotle UPC/PLU: 48000024272
Chili Firehouse HSH UPC/PLU: 48000035037
Southwest Stuffed Sweets HSH CC UPC/PLU: 28634600000; Southwest Stuffed Sweets HSH FP UPC/PLU: 26066400000
Burrito, Black Bean UPC/PLU: 00000480430
Dip, Mexican Layer Large UPC/PLU: 00000480504; Dip, Mexican Layer Small UPC/PLU: 00000480505
Enchilada, Adobo Black Bean UPC/PLU: 26735600000
HotBar, NE Tofu Meatloaf UPC/PLU: 48000088750
HotBar, Latin Comfort, Stewed Black Beans UPC/PLU: 48000088655
Quesadilla, Vegan Beef UPC/PLU: 27267700000
Salad, Bowl, Mediterranean UPC/PLU: 00000480502
Salad, Papas con Remolachas UPC/PLU: 48000086479
Vegetarian, NEW Falafel UPC/PLU: 48000025248
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9%  in sodium chloride injection.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection due to observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Methylcobalamin 1000 mcg/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Sodium Tetradecyl 1% Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Laureth-P 1% Injection (Polidocanol), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Trimix #1 (Original) Injection (papaverine 75 mg - phentolamine 2.5 mg - PGE 25 mcg/10 mL), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Dexamethasone 4 mg/mL Iontophoresis, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Fortifed Tobramycin 15 mg/1 mL Opth., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Glycerin 98.5% Opth. Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Serum 50% BSS 50% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Progest 200 mg/1 mL Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Estradiol 0.01% Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Estriol 5% Cream Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Naltrexone 4.5 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Ibuprofen 10% cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Acetylcysteine 10% Opth Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Pregnenolone 20 mg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
BLT New Formula 20%/7%/7% Sample, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Keto 10%-Gabap 10%-Ketamine 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Baclofen 20 mg/4 mL Susp., Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
T4 66mcg - T3 10mcg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Promethazine 25 mg/0.5 mLGel, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Leucovorin 1 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Diclo 3% - Bacl 2% - Cyclo 2% - Lidoc 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Warfarin 2.5 ng Lactose Free Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Nitroglycerin 0.2% Compd Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Pyrimethamine 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Nortriptyline 10 mg/5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Nadolol 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Rifampin 25 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Nexium 2 mg/1 mL Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Hydroquinone 10% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Fortified Vancomycin 25 mg/1 mL Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Folic Acid 2 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Pyridoxine 100 mg/1 mL Syrup, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Renacidin Irrigation Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Hydroxyurea 100 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Verapamil HCl 15% Topical Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Sildenafil 10 mg/1 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Ciprodex with Amphoteracin B (ear drops), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
DNCB 0.3% Ointment, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Methenamine/Phenyl Salicylate Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Thymol 2% Solution, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Lansoprazole 3 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Triest 5 mg - Progest 150 mg Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Cyclandelate 200 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Coconut Oil Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Nystatin 50,000 Units Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Hydrocortisone 1.6 mg/0.5 mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Phen 15 mg - Topri 92 mg SR Cap (Qsymia), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17.    Used as a humidifier in a breathing circuit.
Product code: 6160, Batch number: 110208-50
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
The American National Red Cross - Southern Region
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Nationwide to the following; CA, NV, AZ, WA, OR, CO, UT, ID, TX, MA, RI, ME, NH, CT, VT, NY, NJ, KY, VA, PA, DE, DC, MD, TN, MI, IN, OH, IL, MO, WI, MN, NE, KS, GA, NC, SC, LA, FL.   No foreign distribution.
Trader Joe's Nuts Raw California Walnut Pieces  NET WT. 16oz. (1 LB) 454g  UPC 00373685    Trader Joe's Nuts  Raw California Walnut Halves & Pieces  NET WT. 16 OZ (1 LB) 454g  UPC 00943338    Trader Joe's Nuts  Raw California Walnut Baking Pieces  NET WT. 16 OZ (1 LB) 454g  UPC 00519342    Trader Joe's Nuts  Raw California Premium Walnut Halves  NET WT. 16 OZ (1 LB) 454g  UPC 00519328    Trader Joe's Organic  Raw Walnut Halves & Pieces  NET WT. 16 OZ (1 LB) 454g  UPC 00586627    The products are packaged in clear bags with UPC Codes printed on the back.  For Raw California Walnut products, the ''BEST BY'' dates and Lot Numbers can be found printed on the back of the packages.  For the Organic Raw Walnut products, the ''BEST BY'' dates can be found printed on the front of the packages.
Trader Joe's Nuts Raw California Walnut Pieces--16 oz. UPC: 00373685  Best By Date: 12/2015  Lot Numbers: GU4345    Trader Joes Nuts Raw California Walnut Halves & Pieces  16 oz  UPC: 00943338  Best By Date: 12/2015  Lot Numbers: GU4346, GU4349, GU4356    Trader Joes Nuts Raw California Walnut Baking Pieces  16 oz  UPC: 00519342  Best By Date: 12/2015  Lot Numbers: GU4350    Trader Joes Nuts Raw California Premium Walnut Halves  16oz  UPC: 00519328  Best By Date: 12/2015  Lot Numbers: GU4343, GU4344, GU4351, GU4352    Trader Joes Organic Raw Walnut Halves & Pieces  12oz  UPC: 00586627  Best By Date: OCT 15 2015, OCT 16 2015, OCT 17 2015, OCT 20 2015, OCT 21 2015, NOV 17 2015, NOV 18 2015, NOV 19 2015, NOV 20 2015, NOV 28 2015, DEC 01 2015
The firm is recalling Raw Walnuts because the products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
US Nationwide distribution in the states of MA and RI.
Kinemax Stem Extenders, 80 mm,  Product Usage:  Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.
Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.
Product shipped to distributors in the following states: NY, CT, NH, RI, MA, CA, MD, ME, MN, PA and Nationwide through retail stores. Canada:  Winners, HomeSense and Marshalls stores Bermuda
Walnuts: America Choice, 12 oz. Plastic Pouch, UPC: 75480779049; Aurora , 6.5 oz. Plastic Cup, UPC: 65585200097; Aurora, 14.0 oz. Plastic Tub, UPC: 65585200070; Aurora, Bulk, NO UPC; Aurora, 4.0 oz. Plastic Pouch, UPC: 65585200490; Aurora, 12.0 oz. Plastic Pouch, UPC: 65585200316; Belmont Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Ernest Klein, 6.5 oz. Plastic Cup, UPC: 65585200097; Food Emporium Brand Products, 14.0 oz. Plastic Tub, UPC: 1119079096; Food Emporium Brand Products, 12.0 oz. Plastic Pouch, UPC: 72297451004; Gauls Market Brand Products, 6.5 oz. Plastic Cup, UPC: 65585200097; Giant Carlisle Food Store, 6.5 oz. Plastic Cup, UPC: 68826713594; Giant of Maryland, 6.5 oz. Plastic Cup, UPC: 68826713594; Gourmet Garage, 6.5 oz. Plastic Cup, UPC: 79084505931; Gourmet Garage, 14.0 oz. Plastic Tub , UPC: 79084505371; Harvest Co  Op Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Hurley Ridge, 6.5 oz. Plastic Cup, UPC: 65585200097; Hurley Ridge, 12 oz. Plastic Pouch, UPC: 65585200316; Lees Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Martins Food, 6.5 oz. Plastic Cup, UPC: 68826713594; Palmers Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Stop & Shop, 6.5 oz. Plastic Cup, UPC: 68826713594; Union Market, 6.5 oz. Plastic Cup, UPC: 65585200097; Walter Stewart Market, 14.0 oz. Plastic Tub, UPC: 65585200070; Wild Acorns, 6.5 oz. Plastic Cup, UPC: 81957401075; Wild By Nature Brand Products, 6.5 oz. Plastic Cup, UPC: 65585270097; Windfall Market, 6.5 oz. Plastic Cup, UPC: 65585200097
Best if used by date range: 10/29/15  12/7/15
4  Section Nut Tray Assortment:  Aurora 13 oz. Plastic Tray UPC: 65585200141; Food Emporium Brand Products 13 oz. Plastic Tray UPC: 1119079011
Best if used by date range: 11/6/15  12/10/15
5 K Omega Trail Mix: Aurora  20 oz. Plastic Cup  UPC: 65585200121; Aurora, 10 oz. Plastic Cup UPC: 65585200703; Belmont Market 10 oz. Plastic Cup; UPC: 65585200703; Gourmet Garage 10 oz. Plastic Cup UPC: 79084505947 Union Market 10 oz. Plastic Cup UPC: 65585200703
Best if used by date range: 11/3/15  11/16/15
6  Section Nut Tray Assortment: Aurora, 26 oz. Plastic Tray, UPC: 65585200145; Food Emporium Brand, 26 oz. Plastic Tray, UPC: 1119079012
Cranberry Health Mix:  America Choice, 16 oz. Plastic Pouch, UPC: 75480779046; Aurora , 9.25 oz. Plastic Cup, UPC: 65585200288; Aurora , 10.0 oz. Pillow Pouch, UPC: 65585200826; Aurora, 16.0 oz. Plastic Pouch, UPC: 65585200827, Aurora , 18 oz. Plastic Pouch , NO UPC; Aurora , 21 oz. Plastic Cup, UPC: 65585200585; Aurora , 4.5 oz. Single Serve, UPC: 65585200208; Aurora, 1.35 oz. Single Serve, UPC: 65585200574; Aurora  Bulk, NO UPC; Belmont Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Belmont Market, 21 oz. Plastic Cup, UPC: 65585200585; Citarella Brand Products, 9.25 oz. Plastic Cup, UPC: 79084505949; Citarella Brand Products, Bulk, NO UPC; Food Emporium Brand Products, 7.5 oz. Gift Bag, UPC: 1119079044; Food Emporium Brand Products, 21 oz. Plastic Cup, UPC: 1119079010; Gauls Market Brand Products, 9.25 oz. Plastic Cup, UPC: 65585200288, Gauls Market Brand Products, 21 oz. Plastic Cup, UPC: 65585200585; Giant Carlisle Food Store, 21 oz. Plastic Cup, UPC: 68826713692; Giant Carlisle Food Store, 9.25 oz. Plastic Cup, UPC: 68826714713; Giant of Maryland, 21 oz. Plastic Cup, UPC: 68826713692; Giant of Maryland, 9.25 oz. Plastic Cup, UPC: 68826714713; Gourmet Garage, 9.25 oz. Plastic Cup, UPC: 79084505949; Gourmet Garage, 21 oz. Plastic Cup, UPC: 79084505603; Green Hills Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Green Hills Market, 21 oz. Plastic Cup, UPC: 65585200585; Harvest Co  Op Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Hurley Ridge 9.25 oz. Plastic Cup, UPC: 65585200288; Hurley Ridge, 21 oz. Plastic Cup, UPC: 65585200585; Lees Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Lees Market, 21 oz. Plastic Cup, UPC: 65585200585; Martins Food, 21 oz. Plastic Cup, UPC: 68826713692; Martins Food, 9.25 oz. Plastic Cup, UPC: 68826714713; Miles Market, 9.25 oz. Plastic Cup, UPC: 65585200288; Stop & Shop, 21 oz. Plastic Cup, UPC: 68826713692; Stop & Shop, 9.25 oz. Plastic Cup, UPC: 68826714713; Union Market , 9.25 oz. Plastic Cup, UPC: 65585200288; Whole Foods Market , 9.25 oz. Plastic Cup, UPC: 655852002
Forest Bounty Grail Mix: Aurora, 13 oz. Plastic Cup, UPC: 65585200571; Aurora,  13 oz. Plastic Pouch, UPC: 65585200290; Aurora, 17.5 oz. Plastic Cup, UPC: 65585200496
Best if used by date range: 10/28/15  12/13/15
Raisin Nut Party Mix: Aurora, 11.0 oz. Plastic Cup, UPC: 65585200094; Ernest Klein, 11.0 oz. Plastic Cup, UPC: 65585200094, Food Emporium Brand Products, 7.5 oz. Gift Bag, UPC: 1119079050; Gauls Market Brand Products, 11.0 oz. Plastic Cup, UPC: 65585200094; Harvest Co  Op Market, 11.0 oz. Plastic Cup, UPC: 65585200094; Hurley Ridge, 11.0 oz. Plastic Cup, UPC: 65585200094; Wild Acorns, 11.0 oz. Plastic Cup, UPC: 81957401031
Best if used by date range: 11/10/15  12/10/15
Roasted Mixed Nuts No Salt: Gourmet Garage, 9 oz. Plastic Cup, UPC: 79084506010; Hannaford, 9.0 oz. Plastic Cup, UPC: 72543994507
Best if used by date range: 11/10/15  12/19/15
San Fernando Sunshine Mix: Gourmet Garage, 11 oz. Plastic Cup, UPC: 79084505936
Deluxe Mixed Nuts with Sea Salt: Aurora, Bulk; Gourmet Garage,  9 oz. Plastic Cup, UPC: 79084505945
Best if used by date range: 11/18/15  12/19/15
Deluxe Mixed Nuts No Salt: Aurora, Bulk, NO UPC
Roasted Salt Mixed Nuts: Aurora, 4.5 oz. Plastic Pouch, UPC: 65585200252; Aurora, 20 oz. Plastic Tub, UPC: 65585200340; Aurora, 10 oz. Plastic Pouch, UPC: 65585200804, Aurora, Bulk, No UPC, Belmont Market, 20 oz. Plastic Tub, UPC: 65585200340, Food Emporium Brand Products, 6.5 oz. Gift Bag, UPC: 1119079042; Food Emporium Brand Products, 20 oz. Plastic Tub, UPC: 1119079095, Gauls Market Brand Products, 20 oz. Plastic Tub, UPC: 65585200340; Giant Carlisle Food Store, 9.0 oz. Plastic Cup, UPC: 68826714736; Giant of Maryland, 9.0 oz. Plastic Cup, UPC: 68826714736;  Martins Food, 9.0 oz. Plastic Cup, UPC: 68826714736; Stop&Shop, 9.0 oz. Plastic Cup, UPC:  68826714736; Aurora, 9.0 oz. Plastic Cup, UPC: 65585200084; Ernest Klein, 9.0 oz. Plastic Cup, UPC: 65585200084; Gauls Market Brand Products, 9.0 oz. Plastic Cup, UPC: 65585200084; Harvest Co  Op Market, 9.0 oz. Plastic Cup, UPC: 65585200084; Hurley Ridge, 9.0 oz. Plastic Cup, UPC: 65585200084 11/4/15  12/13/15  Palmers Market  Roasted Salt Mixed Nuts  9.0 oz. Plastic Cup 65585200084 11/4/15  12/13/15  Wild Acorns  Roasted Salt Mixed Nuts  9.0 oz. Plastic Cup 81957401052 11/4/15  12/13/15  Wild By Nature Brand Products Roasted Salt Mixed Nuts  9.0 oz. Plastic Cup 65585270084 11/4/15  12/10/15; Gourmet Garage, 9 oz. Plastic Cup, UPC: 79084505922; Gourment Garage, 20 oz. Plastic Tub, UPC: 79084505842
Spinach & Goat Cheese Pizza (Focaccia) Mackenzie Limited Spinach & Goat Cheese Focaccia 18 PCS #SGC18   Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Asparagus Roll Ups; Asparagus Roll-Up 100 PCS v2002 15075 Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Shrimp Maui; Maui Shrimp 100 pcs S5036 15075     Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Lobster & Shrimp Spring Rolls     Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Appetizer Size Lobster Spring Rolls 80 PCS L1046 15075        Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Spicy Shrimp Chopsticks 80 PCS S5038 15075          Products are placed on plastic trays, shrink wrapped, placed in boxes, labelled, & shrink wrapped.
Apricot Filled Cookie OTC Sell By: (all dates up to) 3/23/2015  Net WT. 1 OZ  Contains:Egg, Wheat, Soy  ;   OTC Raisin Filled Cookie  Sell By: (all dates up to) 3/23/2015  Net WT 2 OZ  Contains: Egg, Wheat Soy  ;   Cookies affected are only sold direct from bakery counter and packaged at time per customer request and packed either in clam shell plastic or wax paper.  ;   Net Weight on label may differ depending on number of cookies a customer requested. Net Weights listed above are for 1 cookie.
Raisin filled: 4294 cookies; Apricot Filled 2731 cookies
On 3/20/2015, it was discovered that the labels for Apricot Filled Cookie and Raisin Filled Cookie, served over the counter at retail Eagle and affiliate stores, did not declare the milk allergen. Milk was not included on the labels which state ''contains: egg, wheat, soy.''
Nature's Eats Natural Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00912-7; Central Market Macadamia Nuts NET WT 6 oz. (170g) in clear cello bags, UPC: 8-32112-00820-5
Nature's Eats Lot Code: 31435001 BEST BY 23DEC15; 35014001 BEST BY 06JAN16; 35352001 BEST BY 26JAN16; 31133001 BEST BY 12DEC15. Macadamia Nuts Lot Code: 35090001 BEST BY 08JAN16; 35699001 BEST BY 17FEB16
Nature's Eats Mustang Island Macadamia Sunrise NET WT 14 oz. (397g) Trail Mixes in clear cello bags, UPC: 8-32112-00363-7
Lulu DK JOICO TURN HEADS, Metallic Temporary Tattoos
Product recalled due to undeclared ingredients.
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection,  Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, which tested negative for HTLV-I/II, but was collected from a donor who was previously deferred for testing positive for HTLV-I/II, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD.   Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD.     Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD.     Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR  and the country of Canada.
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8  Synapse Cardiovascular v4.0.8 SR1  Intended Use:  Picture Archiving and Communication System  Computer, Diagnostic, Programmable
Software Versions: Synapse Cardiovascular v4.0.8  Synapse Cardiovascular v4.0.8 SR1
Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
Worldwide Distribution - US including CA, FL, IL, IN,  MD, MI, MN, MO, NC, NY, OH, OR, PA, PR,  TX, VA,  WI Foreign: Canada
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System  Software versions:  Synapse Cardiovascular v4.0.8  Synapse Cardiovascular v4.0.8 SR1
Software versions: Synapse Cardiovascular v4.0.8  Synapse Cardiovascular v4.0.8 SR1
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Plain Bagels; Sell By: (up to and including) 04/02/15; UPC: 67785 30499; Net Wt 22oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238;   Plastic bag contains 6 bagels.
Sell By: (up to and including) 04/02/15; UPC: 67785 30499
Giant Eagle recalls various products due to undeclared wheat & soy.
Asiago Bagels; Sell By: (up to and including) 04/02/15; UPC: 09741 30449; Net Wt 20oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238;   Plastic bag contains 6 bagels.
Sell By: (up to and including) 04/02/15; UPC: 09741 30449
Giant Eagle recalls various products due to undeclared soy.
Dinner Sourdough Bread; Sell By: (up to and including) 04/02/15; UPC: 67657 00199; Net Wt 9.0oz; Contains: Wheat; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238;   Plastic bag contains 6 bagels.
Sell By: (up to and including) 04/02/15; UPC: 67657 00199
Lemon Almond Chicken Salad Wrap; Sell By: (up to and including) 04/01/15; UPC: 47235 80499; Net Wt 9.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238   Packed in rigid plastic.
Sell By: (up to and including) 04/01/15; UPC: 47235 80499;
Giant Eagle recalls various products due to undeclared milk.
Lemon Almond Chicken Salad Wedge; Sell By: (up to and including) 04/01/15; UPC: 67093 20399; Net Wt 7.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238   Packed in rigid plastic.
Sell By: (up to and including) 04/01/15; UPC: 67093 20399
Lemon Almond Chicken Salad Sliders; Sell By: (up to and including) 04/01/15; UPC: 77183 60299; Net Wt 6.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238   2 sliders Packed in rigid plastic.
Sell By: (up to and including) 04/01/15; UPC: 77183 60299
Rotisserie Lemon Almond Chicken Salad; Sell By: (up to and including) 04/01/15; UPC: 55708 90899; Net Wt 16.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238   Rotisserie Lemon Almond Chicken Salad; Sell By: (up to and including) 04/01/15; UPC: 56839 60917; Net Wt 16.0oz; Keep Refrigerated; Giant Eagle; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238
Sell By: (up to and including) 04/01/15; UPC: 55708 90899;   Sell By: (up to and including) 04/01/15; UPC: 56839 60917;
154 units for 55708 and 484 units for 56839
Giant Eagle Maryland Style Crab Cake; Sell By: 04/04/2015; PLU#: 47538; Contains Wheat, Egg, Soy, Milk; Keep Refrigerated; Distributed by Giant Eagle, Inc., Pittsburgh, PA 15238
Sell By: (up to and including) 04/04/15; PLU#47538
Giant Eagle recalls various products due to undeclared fish/anchovies (worchestershire).
Starlight Candies Giant Eagle  Bulk Candies  Bulk Bin tag #63826
This product is sold from bulk bins only. No package label or codes.
Giant Eagle recalls various products due to undeclared soy lecithin.
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM.   The Dimension EXL clinical chemistry system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low.
Nationwide and internationally to Canada via wholesale and retail distibution, and internet sales direct to consumers.
Nourish Organic Face Cream, Argan & Pomegranate, Sensible Organics Inc., Beaver Falls, PA 15010, 1.7 fl. oz./50 mL, Nourish Organic Face Cream packaged in 50 mL white barrel with airless pump & plastic cap, 12 units/case for each product
All lot codes of Nourish Organic Face Lotion and Nourish Organic Face Cream were recalled because the products may contain mold. No illnesses have been associated with these products.
Nourish Organic Face Lotion, Argan & Rosewater, Sensible Organics Inc., Beaver Falls, PA 15010,  1.7 fl. oz./50 mL, in 2 oz. white cosmo oval with smooth black pump & plastic cap, 12 units/case for each product
KT's Energy Bars, net weight per bar is 2.9 oz (82.21 g).
KT's Energy Bars are recalled due to undeclared soy lecithin.
KT's Energy Bars - Dairy Free!, net weight per bar is 2.9 oz (82.21 g).
KT's Energy Bars - Dairy Free! are recalled due to undeclared soy lecithin.
KT's Paleo Chocolate Chip Cookies, 2 cookies per package
KT's Paleo Chocolate Chip Cookies are recalled due to undeclared soy lecithin.
KT's Energy Bars  No Nuts/Dairy Free. 2.9 oz./82.21 gram bar packaged in saran wrap
KT's Energy Bars  No Nuts/Dairy Free is recalled due to undeclared sulfite and because the coconut is declared in the ingredients statement but the product name is listed No Nuts.
Domestic: IN, MI, LA, MN, PA, IL, GA, HI, NY, CA, FL, SC, KY, TX, OR, DE, IA, TN, VA, MD, MA, NH   Foreign: None    DOD/VA: None
Terra Spice Company Jalapeno Cheddar (dry spice mix).  Sold in 0.5, 1, 3, or 5 qt. jars, 6x10 stand up pouches, and bulk up to 50 lbs
All lots-the firm does not place manufactuiring codes on products.
Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection  (inspection dates 3/24, 26/2015).  Label lists cheddar and sour cream but does not specifically declare milk.
Terra Spice Company the Greek (dry spice mix),New Kitchen Store the Greek (dry spice mix),Sawyer Home & Garden Center the Greek (dry spice mix),SPICE MERCHANTS the Greek.    Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection  (inspection dates 3/24, 26/2015). Label lists feta cheese but does not specifically declare milk.
Terra Spice Company basil walnut pesto blend (dry spice mix), SPICE MERCHANTS basil walnut pesto blend. Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
257.64 lbs. distributed in commerce during that time period
Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection  (inspection dates 3/24, 26/2015). Label lists parmesan cheese and romano cheese but does not specifically declare milk
Terra Spice Company Italian Seasoning w/ romano (dry spice mix), New Kitchen Store Italian seasoning w/ romano (dry spice mix), Regal Rabbit Italian seasoning w/ romano (dry spice mix), Sawyer Home & Garden Center Italian seasoning w/ romano),SPICE MERCHANTS Italian seasoning w/ romano.    Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection  (inspection dates 3/24, 26/2015). Label lists romano cheese but does not specifically declare milk
Terra Spice Company buffalo wing rub (dry spice mix).  Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
103.4 lbs. distributed in commerce during
Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection  (inspection dates 3/24, 26/2015). Label does not declare soy and wheat.
Terra Spice Company barbeque spice blend (dry spice mix), New Kitchen Store barbeque spice blend (dry spice mix), Sawyer Home & Garden Center barbeque spice blend, WILD ONION Spice Company barbeque spice blend.   Sold in 0.5, 1, 3, or 5 qt. jars, 4x6 and 6x10 stand up pouches, and bulk up to 50 lbs
Greenies, LLC dba Terra Spice Co. decided to conduct a voluntary recall during an FDA inspection  (inspection dates 3/24, 26/2015). Label lists lecithin but does not specifically declare soy
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30
4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
World Wide Gourmet Foods, Inc. dba Alaska Smokehouse
Central Market Teriyaki Salmon Jerky,  3 oz. per plastic retail pouch.    The front label is correctly identified as Teriyaki Salmon Jerky, but the back side was mis-labeled as Smoked Salmon Jerky with the UPC 0 41220 34270 9.
Central Market Teriyaki Salmon Jerkey is recalled due to undeclared soy and wheat.
Blood products, which were not quarantined subsequent to receiving information regarding a post donation illness, were distributed.
Blood and Blood Products for Reprocessing
Blood product, in which quality control and distribution/failure to quarantine unit due to medical history, was distributed.
Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
Spinal Elements 5.5 x 45MM Mercury lordosed rod.  A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.
The firm is recalling three lots of 5.5 x 45MM Mercury lordosed rod because some products may not meet the appropriate traceability requirements including the lot number.  Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod.  The lack of marking interrupts the ability to maintain traceability of the device.
Blood products, for which quality control and distribution of products did not meet specifications, were distributed.
Peterson's Macadamias Net Wt 16 oz. (454g) King Nut Companies Solon, OH 44139 www.petersonsnuts.com INGREDIENTS: Macadamia Nuts, Peanut and/or Canola Oil, Salt. 0 74870 10365 9
25 Lb box (Roasted Salted) Code = Item # 00265 - K/N Lot # 5022-1; 16 oz bag Peterson (Roasted Salted) Unit Code = item # 7610365 - K/N Lot # 4330 1; 4364 2; 5013 1   25 Lb box (Roasted Salted) Code = Item # 00265 - K/N Lot # 5022-1
176/16 oz pkgs (Roasted); 2/25 lb boxes (Roasted)
The firm was notified by their supplier that the product test positive for Salmonella
Cleveland Crops Chili Cheezy Kale Chips Made with 100% Dehydrated Raw Kale, Raw, Gluten Free, Vegan, No Preservatives FRESH PRODUCE NO SUGAR ADDED  CUYAHOGA COUNTY Board of Developmental Disabilities INGREDIENTS Raw Dehydrated Kale, Tomatoes, Lemon Juice, Chili Powder, Garlic Powder, Onion Powder, Sea Salt. NT WT 2 OZ (56.7) 8 58736 00504 8
The firm was notified by the Ohio Department of Agriculture that they failed to list Raw Cashews in their ingredient statement.
Distribution US Nationwide and Switzerland.
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail.    Potential patient impact:  surgical delay.
Poudre Valley Health Care, Inc. Blood Bank
Blood product, collected from a donor whose hematocrit was tested using a device for which the quality control results were not documented, was distributed.
US Distribution to the states of : FL, CA, NJ, NC and MD.
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch.  Patient transfer aid.
All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied. No injuries were reported.
One customer (restaurant) in Los Angeles, CA
Border Grill Tortilla Soup Item # BOR-010, 3 x 8 lbs bags/case with Lot Codes Numbers between 140409 and 150311    Corn Maiden Foods, Inc.  24201 Frampton Av.  Harbor City, CA 90710    LOT #  Expiration Date Frozen:  Expiration After Thaw: 7 days    Border Grill Tortilla Soup  INGREDIENTS:  Sauce: Water, tomato filets (tomatoes, salt, calcium, chloride, citric acid), fresh tomatoes, onion, garlic, jalapeno chile, chicken base (chicken meat including natural chicken juices, natural sea salt, chicken fat, vegetable extract (potato, carrot, onion), yeast extract, tumeric, natural flavors), Kosher salt, olive oil blend (olive oil, canola oil), chipotle chile, black pepper.    COUNTAINS THE FOLLOWING ALLERGENS: NONE    KEEP FROZEN OR REFRIGERATED  3 Bags x 8 lbs/Case  Net Weights 24 lbs.
Item # BOR-010, 3 x 8lbs bags/case with Lot Codes Numbers between 140409 and 150311
The firm is recalling Border Grill Tortilla soup due to the product having undeclared hydrolyzed soy protein that is a sub-ingredient in the ingredient; chicken base.
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Failed Dissolution Specification; 6 month time point
AR, CA, CO, CT, FL, IL, IN, MD, MA, MI, MN,MS,MO, NE, NH, NJ, NY,OH, PA, SC, UT, VA, WA, WI.
Tastefully Simple, Blackberry Syrup, 12 FL oz ( 360 ml), Item 763905. Ingredients: Corn syrup, blackberries, cane sugar, lemon juice, natural flavor. Container consists of Glass, flask bottle with black boot seal over cap/neck of bottle.    These multi-product items also include Blackberry Syrup:    Rise ,n  Shine Assortment (Item: 101019).  Springtime Celebrations Collection (Item: 100873; Savor Reward Items: 100876, 100885).  TS EatWell Product Pack (Item: 100872; Savor Reward Items: 100879, 100878).  Seasonal Favorites Product Pack (Item: 100874; Savor Reward Items: 100880, 100881).  Large Consultant Assortment - no GWP (Item: 100860).  Consultant Seasonal Assortment -  Large with GWP (Item: 100862).
Presence of suspected mold in some units.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator.  00-2568-000-10.  Zimmer Surgical, Inc.   Intended for post-operative collection of wound drainage.
Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU).  Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.
Purely Elizabeth Cranberry Cashew Ancient Grain Muesli, 10 ounces, packaged in plastic bag sealed into paper cartons, 6 packages per case, Manufactured by Natural Foodworks Group, LLC. Denver, CO
Appetite for Healthy Living (DBA Purely Elizabeth) is recalling Cranberry Cashew Ancient Grain Muesli because an ingredient in this cereal contains sulfur dioxide, which is not declared on the label/ingredient statement.
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 5045-8196-15.
16,861 cartons/6 blister units (28 tablets) each
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Bountiful Harvest Chopped Spinach, KEEP FROZEN, Net Wt. 3 LBS. (1.36kg), Case with 12; Chopped Spinach (Cheney Brothers) 3 pounds, 12 per case;  Essential Everyday Chopped Spinach Net Wt. 10 oz. (283g), 24 per case;  Essential Everyday Chopped Spinach Net wt. 16 oz. (1 LB) 454g, 12 per case;  Fareway Grade A Fancy Chopped Spinach Net WT 10 OZ (284 g), 24 per case;  First Street Chopped Spinach Net Wt. 32 OZ (2 LB) 907g, 12 per case;  Garden Fresh Grade A Fancy 1/20 LBS. Chopped Spinach, 1 bag per case;   Markon First Crop Grade A Fancy Chopped Spinach 12/2 LBS., 12 per case;  Springfield Fancy Chopped Spinach Net Wt 16 OZ (1 LB) 454g, 12 per case;  West Creek Frozen Vegetables Chopped Spinach 1/20 LBS., 1 bag per case;  Magic Harvest Chopped Spinach Net WT. 48oz. (3LBS) 1.36 kg, 12 per case;  Magic Harvest Chopped Spinach Greens Distributed By: Magic Valley Frozen, LLC. McAllen, TX. 78504 1/35 LBS;   Shur Fine Chopped Spinach Net WT 10 OZ (283 g), 24 per case;  Cut Leaf Spinach (Cheney Brothers) 3 pounds, 12 per case;  Essential Everyday Cut Leaf Spinach Net WT 10 oz, 24 per case;  Essential Everyday Cut Leaf Spinach Net WT 16 oz. (1 LB) 454g, 12 per case;  Springfield Fancy Cut Leaf Spinach Net WT 16 OZ (1 LB) 454g,  12 per case;  Frost Sweet Cut Leaf Spinach Distributed By Diversifood Marietta, GA. 30067 Grade A Fancy Product of USA 1/35 LBS.
Lot numbers: (Bountiful Harvest chopped) MV056515, MV05715, MV06015, MV06215, MV06315; (Cheney Brothers chopped) MV06015, MV06115, MV07015; (Essential Everyday 16 oz. chopped) MV07115, MV07715; (Essential Everyday 10 oz. chopped) MV05615, MV05715, MV05815, MV05915, MV06015; (First Street chopped) MV06315, MV06415, MV06515, MV08715; (Garden Fresh chopped) MV09815; (West Creek chopped) MV08715; (Fareway chopped) MV06215, MV06315, MV07315; (Springfield chopped) MV07915; (Markon chopped) 5B28E10D; (Magic Harvest 3 LBS. chopped) MV05715, MV05815, MV07315, MV07415; (Magic Harvest 35 LBS chopped.) MV06615; (Shurfine chopped) C5LN151X, C5LN161X, C5LN142X; (Cheney Brothers cut) MV05715, MV06015, MV06115; (Essential Everyday 10 oz. cut) MV05715, MV06115; (Essential Everyday 16 oz. cut) MV06015, MV06415, MV06815, MV06915, MV07715, MV08615; (Springfield cut) MV07915, MV09015; (Frost Sweet cut) MV06115, MV07415, MV07515
Unapproved pesticide, Lambda-Cyhalothrin, used on the spinach and residual levels were found higher than 0.01 ppm
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium  Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit   Product Usage:  Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Failures of the splice repair kit if exposed to excessive force.
Distribution was made to IA.   There was no foreign/military/government distribution.
D&D Foods, Inc. Summer Fresh Pasta 31830, packaged in 8-lb. plastic buckets.  The firm name on the label is D&D Foods, Inc., Omaha, NE.
Product has the potential to be contaminated Listeria monocytogenes.
US Nationwide in the states of:  AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
Tapered HD Upgrade Set, REF  TSKHDUS, Non-Sterile, Rx Only,    Product Usage  Usage:  Surgical instruments used in preparation for dental implant placement
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Levalbuterol Inhalation Solution, USP, 0.63 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640.  NDC: 43598-412-25.
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Worldwide Distribution - US (nationwide) to the states of:  AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of : Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Egypt, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Lebanon, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, South Korea, Spain,Thailand and United Kingdom.
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60)   Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
Worldwide distribution.  No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
CA, AZ, CO. CT, DC, FL, GA, IL, MA, MD, MD, MI, NJ, NM, NY, OR, PA, UT and WA
Poco Dolce Bittersweet Chocolate: Burnt Caramel Tile, sea salt topped;  0.6 oz (17 grams)  San Francisco CA.  Ingredients:  Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Soy Lecithin, Pure Vanilla) Sugar, Butter, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins.
California Department of Public Health conducted and inspection of the firm and found that milk was missing from the label as an ingredient of butter.
Poco Dolce Bittersweet Chocolate: Almond Tile, sea salt topped;  0.6 oz (17 grams)  San Francisco CA.  Ingredients:  Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins.
Poco Dolce Bittersweet Chocolate: Almond Coconut Tile, sea salt topped;  0.6 oz (17 grams)  San Francisco CA.  Ingredients:  Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Almonds, Coconut, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins.
Poco Dolce Bittersweet Chocolate: Sesame Toffee Tile, sea salt topped;  0.6 oz (17 grams)  San Francisco CA.  Ingredients:  Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Sugar, Butter, Sesame Seeds, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins.
Poco Dolce Bittersweet Chocolate: Ginger Tile, sea salt topped;  0.6 oz (17 grams)  San Francisco CA.  Ingredients:  Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Ginger, Sugar, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins.
Poco Dolce Bittersweet Chocolate: Aztec Chili Tile, sea salt topped;  0.6 oz (17 grams)  San Francisco CA.  Ingredients:  Bittersweet Chocolate (Chocolate Liquor, Sugar, Cocoa Butter, Butter, Soy Lecithin, Pure Vanilla) Pumpkin Seeds, Cinnamon, Ground Chiles, Grey Sea Salt. May contain traces of peanuts, tree nuts or milk proteins.
Worldwide Distribution -  US (nationwide) including Puerto Rico and to the states of : AL, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI  and WV., and to the countries of :  Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Denmark, Egypt, France, Germany, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Republic of Korea, Russia, South Korea, Spain, Sweden, Syrian Arab Republic, Thailand and United Kingdom.
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLAND, FINLAND, and BELGIUM.
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatment.
distributed in North Carolina, Texas, and Wyoming
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.
The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).