Product was distributed to customers in IA, NE, and SD
Peet's, Sup'R Sow Pel, Biozyme Incorporated St. Joseph MO, 50 lb bag
An ingredient used in the manufacture of animal feeds was recalled due to contamination with Salmonella.
Peet's, Flexi-con AMA Meal, Biozyme Incorporated St. Joseph MO, 50 lb bag
Peet's, Flexi-con, Biozyme Incorporated St. Joseph MO, 50 lb bag and bulk
Peet's, Hotchkiss Challenger 34-8, Biozyme Incorporated St. Joseph MO, bulk
Peet's, Pig Start 100, Biozyme Incorporated St. Joseph MO, 50 lb bag
Peet's, 32% Goat Supplement D46 Medicated, Decoquinate 46 grams/ton, Biozyme Incorporated St. Joseph MO, 50 lb bag
Peet's, Hoegermeyer Sow Base Mix Meal, Biozyme Incorporated St. Joseph MO, 50 lb bag
Peet's, 23% Broiler RTN MD CR Medicated, Amprolium 0.025%, Biozyme Incorporated St. Joseph MO, 50 lb bag
Peet's, Base Mix Extra Phy Meal, Biozyme Incorporated St. Joseph MO, bulk
Peet's, Pig Start 300, Biozyme Incorporated St. Joseph MO, 50 lb bag
Always Save    Chicken Flavor Cat Food Net Wt. 13.2 oz    Proudly Distributed By:  Associated Wholesale Grocers, Inc. Kansas City, Kansas 66106    UPC 0-70038-32972-5
This recall has been initiated due to receiving a notification of a consumer complaint regarding foreign material in Doctors Fosters and Smith Chicken and Brown Rice Dog Food.
Wellness Beef & Chicken Formula Net Wt. 12.5 oz.  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-08821-9
This recall has been initiated due to receiving a notification of a consumer complaint regarding foreign material in Drs Fosters and Smith Chicken and Brown Rice Dog Food.
Wellness Turkey & Salmon Formula  Net Wt. 12.5 oz  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-08819-6
Companion with Turkey and Bacon Dog Food  Net Wt. 13.2 oz      Distributed by Foodhold USA LLC Landover, MD 20785     UPC 6-88267-00356-1
Blue Buffalo Homestyle Recipe Healthy Weight Chicken Dinner With Garden Vegetable , Net Wt. 12.5  oz.  Distributed by Blue Buffalo Co., Ltd  11 River Rd. Wilson, CT 06897  UPC 8-40243-10017-0
4Health Chicken & Rice Formula For Dogs  Net Wt. 13.2 oz.  Distributed by:  Tractor Supply Company 200 Powell Place  Brentwood, TN 37027  UPC 7-49394-01849-8
Always Save    Fish Flavor Cat Food Net Wt. 13.2 oz.    Proudly Distributed By:    Associated Wholesale Grocers, Inc. Kansas City, Kansas 66106    UPC 0-70038-32970-1
Wellness Chicken & & Lobster Formula  Net Wt. 12.5 oz  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-08869-1
Doctors Fosters & Smith Chicken and Brown Rice Formula Adult  Dog Food Net Wt. 12.7 oz.  Distributed by Foster & Smith, Inc. Rhinelander, WI 54501-0100  UPC 8-25141-12020-8
Sprout Ultra High Performance Cat Food Country Chicken Dinner    Net Wt. 13.2 oz    Distributed By:    Mills Fleet Farm  PO Box 1199, Appleton, WI 54912      UPC 0-88302-42230-0
4Health Turkey & Salmon Dinner for Cats  Net Wt. 13.2 oz.  Distributed by:  Tractor Supply Company 200 Powell Place  Brentwood, TN 37027  UPC 7-49394-04303-2
Wellness Turkey Formula  Net Wt. 12.5 oz  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-08823-3
Wellness Chicken & Herring Formula Net Wt. 12.5 oz.  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-08820-2
Wellness Chicken Formula Net Wt. 12.5 oz.  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-08822-6
Home 360 Pet    Dog Food with Turkey & Bacon     Net Wt. 13.2 oz     Proudly Distributed By:  DZA Brands LLC 2110 Executive Drive, Salisbury, NC 28147  UPC 7-25439-96016-8
Cat Cuisine Turkey & Giblets Dinner Cat Food Net Wt. 13.2 oz   Distributed by: Save-A-Lot Food Stores, LTD Earth City, MO 63045  UPC 7-37257-26116-7    Net Wt. 13.2 oz.    Distributed By:    Mills Fleet Farm  PO Box 1199, Appleton, WI 54912      UPC 0-51933-46489-6
Sprout Ultra High Performance Dog Food with Beef, Bacon & Cheese    Net Wt. 13.2 oz.    Distributed By:    Mills Fleet Farm  PO Box 1199, Appleton, WI 54912      UPC 0-01304-50491-1
Wellness Beef & Salmon Formula Net Wt. 12.5 oz.  Old Mother Hubbard, Inc.  Tewksbury, MA 01876  UPC 0-76344-09122-6
Triumph Premium Cat Food Ocean Fish Formula  Net Wt. 13.2 oz  UPC 0-73657-00289-5
Companion with Chicken and Rice Dog Food   Net Wt. 13.2 oz    Distributed by Foodhold USA LLC Landover, MD 20785 UPC 6-88267-07501-8
Grreat Choice with Chicken and Rice Classic Ground Dog Food Net Wt 13.2 oz  Dist. by: Pacific Coast Distributing, Inc. 19601 N. 27th Avenue Phoenix, AZ USA 85027  UPC 7-37257-26116-7
4Health Lamb and Rice Formula   Net Wt. 13.2 oz.    Distributed by:  Tractor Supply Company 200 Powell Place  Brentwood, TN 37027  UPC 0-49394-01850-4
Companion with Chicken, Lamb and Rice Dog Food    Net Wt. 13.2 oz   Distributed by Foodhold USA LLC Landover, MD 20785     UPC 6-88267-00360-8
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
NY, RI, PA, OH, IL, GA, MA, SC, NC, TX, NJ, KY, TN    Canada
Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR;     Product Usage:  CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 12FR (4mm);     Product Usage:  CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
CORFLO PEG Kit, Pull 16FR.      Product Usage:  CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Nitroglycerin all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Sodium Citrate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
TPN Neonatal all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Sodium Phosphate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Heparin sodium all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Morphine Sulfate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Oxytocin all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Calcium Gluconate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Bumetadine all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Vancomycin HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Methohexital Sodium all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Nalbuphine all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Famotidine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Labetalol HCl  all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Diltiazem HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Ondansetron HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Fentanyl Citrate and Bupivacaine HCl  all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Rocuronium Bromide all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Esmolol HCl  all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Midazolam HCl  all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Epinephrine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Potassium Phosphate all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Ketamine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Standard Starter TPN all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Meperidine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Lorazepam HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Nicardipine HCl all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Cefazolin all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Lidocaine all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
US:AZ CA FL MA MI MN NC NJ NV NY PA RI TX VT WA  Canada    Product was distributed to 26 accounts.
Wellness Chicken & Lobster Formula, Natural Food for Cats, Net Wt. 12.5 oz (354g); UPC: 0 76344 08869 1
Wellness Chicken & Herring Formula, Natural Food for Cats, Net Wt. 12.5 oz (354g); UPC: 0 76344 08820 2
Wellness Turkey Formula, Natural Food for Cats, Net Wt. 12.5 oz (354g); UPC: 0 76344 08823 3
Wellness Turkey & Salmon Formula, Natural Food for Cats, Net Wt. 12.5 oz (354g); UPC: 0 76344 08819 6
Wellness Canned Chicken Formula, Natural Food for Cats, Net WT. 12.5 oz (354 g)0 76344 08822 6
Wellness Beef & Chicken Formula, Natural Food for Cats, Net Wt. 12.5 oz (354g); UPC: 0 76344 08821 9
Wellness Beef & Salmon Formula, Natural Food for Cats, Net Wt. 12.5 oz (354g); UPC: 0 76344 09122 6
Medtronic Inc., Cardiac Rhythm and Heart Failure
USA:  Nationwide including DC & PR.    Worldwide- Distribution :  Australia	Egypt	Ireland	Morocco  Austria	Finland	Israel	Netherlands  Bangladesh	France	Italy	New Zealand  Belgium	Germany	Japan	Norway  Brunei Darussalam	Greece	Jordan	Oman  Canada	Guadeloupe	Kuwait	Poland  Cayman Islands	Hong Kong	Lebanon	Portugal  Cyprus	Hungary	Luxembourg	  Denmark	India	Macedonia	Reunion  Dominican Republic	Iran	Malaysia	Singapore
Amplia MRI Quad CRT-0 SureScan  Claria MRI Quad CRT-D SureScan  Compia MRI Quad CRT-D SureScan
Product sold nationwide through internet sales.  No foreign consignees were reported.
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
All lot codes, manufacturing codes and expiration dates.
Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ
2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL)
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Alprazolam Extended-release Tablets, USP, 1 mg,  60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc.,  Morgantown, WV 26505 U.S.A.,  NDC 0378-5022-91
US: AK, AL, AR, AZ. , CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY,  OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI,     AUSTRIA, GERMANY, JAPAN, SWITZERLAND.
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only,  Part Number: 7-10014, Model Number: SIP-3000.
Cardiovascular Systems, Inc. (CSI). has initiated a  recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017.  The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.
American Red Cross Blood Services Tennessee Valley Region
Texas; Alabama; Tennessee; California; Mississippi
Blood products, lacking assurance of sterility, were distributed.
Red Blood Cells, Leukocytes Reduced, Irradiated
lood products, lacking assurance of sterility, were distributed.
Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA  90061.
Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA  90061, NDC 54973-3197-1, UPC 3 54973 31971 4.
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
AXIOM Sensis, Computer, Diagnostic, Programmable.    Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology studies.
An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its functions can not be used. Clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
LifeSouth Community Blood Centers Inc - Birmingham Region
HCSC-Blood Center dba as Miller-Keystone Blood Center
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
American National Red Cross (The) Carolinas Region
Blood products, collected from a donor who provided high-risk behavior, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Apheresis Red Blood Cells, Leukocytes Reduced
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2),  c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967     Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01),  Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011
cGMP Deviations: lack of quality assurance at the API manufacturer.
Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b)  5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d)  100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967      Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV  26505 U.S.A., Made in India.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC  29403, USA, Product of India.
Blood product, collected from a donor with a history of jaundice, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use,     Product Usage:  Catheter Connector/Accessory
Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
INFANT 20/BX, Sterile, Single use    Product Usage:  Catheter Connector/Accessory
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use,     Product Usage:  Catheter Connector/Accessory
PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use,    Product Usage:  Catheter Connector/Accessory
Pointe Scientific Chemistry Controls Level I and II    LEVl: Amber glass vial w/PP white plastic cap.  LEV2: Amber glass vial w/PP black plastic cap.
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator.    Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
10-1398M - SpF-PLUS Implantable Stimulator.    Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ  08512, NDC 47335-343-83.
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Presence of Particulate Matter: human hair found within an internal sample syringe.
Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
Distributed to the states of AZ, CT, FL, GA, IL, IN, LA, MI, NY, NC, OH, OK, TX, and VT.
Merge Cardio software.  The firm name on the label is Merge Healthcare, Hartland, WI.      Intended to be used to acquire, store, print, transfer, and archive clinical information.
30 sites have the potentially affected software versions
Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.  For Single Use Only.  Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Product's seal possibly compromised, potentially compromising the sterility of the package contents.  Use of impacted products could result in an increased risk of infection.
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only.  For Single Use Only.     Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only.  For Single Use Only.     Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only.  For Single Use Only.  Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only.  For Single Use Only.  Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only.  For Single Use Only.  Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Catalog Number: JP-HUF100  Lot Numbers:  1161357  1161466  1170015
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar.  Sterile, Rx Only.  For Single Use Only.     Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Catalog Number: JP-HUF101  Lot Numbers:  1161358
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR.  Sterile, Rx Only.  For Single Use Only.    Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only.  For Single Use Only.   Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only.  For Single Use Only.     Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
Nationwide Distribution -  Internationally to Canada.       No govt/VA/Military consignees.
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
CO, WA, TX, SC, PA, NY, WI, VA, CA, MO, KS, IN, AR, AL, SD, OH, Canada, GA, MA, MN, TN, IA, MI, MS, IL
Dip Trio Mix Homemade Gourmet Dip Mix Net Wt. 2.9 oz.  Distributed by: Phoenix Food, LLC. Canton, TX 75103 www.homemadegourmet.com
Worldwide distribution:  US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
US Nationwide distribution in the states of CA, FL, MD and VT
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241    Product Usage:  Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058      ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
Potential performance issue on strain categorization.
Organic Veda brand Ginger Powder, 24 jars, Net Wt. 16 oz. (454 grams)
Lord Organics is recalling ginger powder because it has the potential to be contaminated with Salmonella.
Batch No: A324DGRP, MFD: AUG 2015, Best before: July 2017
AR, AZ, CA, CO, CT, FL, GA, IA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI
7 OZ PIZZA DOUGH BALL, PRODUCT CODE 11267, UPC 0 00 49800 1267 4, NET CASE WT 12.9 KG (28 LB 7 OZ), UNIT NET WT: 198 G (7 OZ), COUNT: 65 --- PROCESSED IN CANADA, DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
13,043 cases US (total for all products)
The product was made with flour supplied by Ardent Mills who issued a recall on flour products due to possible E. coli 0121 contamination.
ARTISAN CRUST PIZZA DOUGH 24/18, PRODUCT CODE 11413, UPC 1 00 49800 11413 2, NET CASE WT: 27 LB (12.2 KG), UNIT NET WT: 18 OZ (1 LB 2 OZ) (510G), COUNT: 24 --- PROCESSED IN CANADA DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
ARTISAN-STYLE PIZZA DOUGH BALL distributed under the following sizes and Product Codes: (a) 12 OZ ARTISAN-STYLE PIZZA DOUGH BALL, RICH'S label, Product Code 11268, UPC 0 00 49800 11268 1, NET CASE WT:  12.2 KG (27 LB), UNIT NET WT: 340 G (12G), COUNT: 36; (b) 18 OZ ARTISAN-STYLE PIZZA DOUGH BALL, Product Code 11269, UPC 0 00 49800 11269 8, NET CASE WT: 12.2 KG (27 LB), UNIT NET WT: 510 (G) (1 LB 2 OZ), COUNT: 24;  and (c) 22 OZ ARTISAN-STYLE PIZZA DOUGH BALL, Product Code 11270, UPC 0 00 49800 11270 4 , NET CASE WT: 13 KG (28 LB 14 OZ), UNIT NET WT: 623 G (22 OZ) (1 LB 6 OZ), COUNT: 21 --- PROCESSED IN CANADA, DIST. BY RICH PRODUCTS CORPORATION, BUFFALO, N.Y. 14213 U.S.A.
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Lot #: WXWZ, Exp. March 2019;  WXTS, Exp. October 2019
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
Implant Direct Sybron Manufacturing, LLC
Worldwide Distribution - Nationwide Distribution  and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and  Japan
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
US: CA, TX, NC, NY, VA, HI, GA, WA, IL, PA, OK, MO, MD, NJ.    Korea.
Herbal Tea Variety 120 ml/pouch, 40 pouches/case
US Deer Antler Export and Import is recalling a variety of Herbal Teas because they may be contaminated with Clostridium botulinum
Bean Sprout 10 lbs. bag, 10lb box, 12/12oz, 20/15oz, 24/1.5 lbs., 5lbs. bag, 3lb tray
Fuji Natural Foods, Inc. is voluntarily recalling all Mung Bean Sprout products because they may contain a foreign object.
Product was shipped to the following states: CA, OH, NJ & NY.
Slow Roasted Ham & Swiss Breakfast Sandwich, Fully Cooked/Keep Frozen/Perishable Net Wt 5.6 oz (159 g) MANUFACTURED EXCLUSIVELY FOR STARBUCKS COFFEE COMPANY SEATTLE, WA 98134 UPC 7 62111 10495 1
The product may be contaminated with Listeria monocytogenes.
Yellowfin Tuna Hilo Cubes, Random cut.  15 lb. cases. (1 x 15 lb. bags per case)  Brand name: Reel Fresh  UPC: 664183001454  Ingredients: Frozen tuna and carbon monoxide (to promote color retention).  Product of Indonesia, Wild Caught
Frozen raw tuna cubes from Indonesia tested positive for hepatitis A.
Manufacturing lot code 633671;  Los Angeles warehouse lot number 174127.   Products were transferred to a storage facility in Hawaii and assigned a new lot code number 5005125.  Hilo/Tropic Fish lot number 609149
Nationwide thru one wholesale located in IL
Nutty INFUSIONS Roasted Cashew Butter, NET WT. 10 OZ (284 g)
Nutty INFUSIONS Ginger Wasabi Cashew Butter, NET WT. 10 OZ (284 g)
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA  NDC 61554-232-40
GMP Deviations; product may not meet cGMP requirements
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL  35811, NDC 0603-7785-52.
Superpotent Drug: above specification for the assay.
Nationwide.  States included are CA, TX, MO, HI, NV, WA, AZ, CO.  No foreign or VA/govt/military consignees.
Schiff Move Free Advanced Plus MSM & Vitamin D3 with Glucosamine + Chondroitin, 80 Coated Tablets, Dietary Supplement, Product item number: 20525-11873
RB Manufacturing is recalling Move Free Advance Tablets due to incorrect packaging.
US:  4 in Texas, 1 in Nevada, 1 in Washington, 22 in California
Sugar Crackers 400g (14.1oz) x 12 packets per carton/case, UPC 9556184 500023
U Can Food Trading is recalling Sugar Crackers because they may contain undeclared soy.
USA (nationwide) Distribution and Internationally to one customer in Canada, and govt/VA/military
MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml).  Product No. : 02.0027, 020510 (carton of 6 of 02.0027).  Polyethylene bottle    Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments. The conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and do not come into contact with the patient.
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Chef Luca's Italian Gluten Free Foods Lasagna Al Forno Baked Cheese Lasagna, 15 oz . frozen  UPC Code: 85573103116
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
SAMI'S BAKERY, MILLET & FLAX, CHOCOLATE CHIP COOKIE, Packed by: Sami's Pita Bakery Inc., Tampa, FL
Blood product, mislabeled as leukoreduced, was distributed.
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
Defective Delivery System: Elevated number of units with out of specification results for leak rate
American Red Cross Blood Services Heart of America Region
Plateletpheresis products, lacking assurance of proper leukoreduction, were distributed.
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
Plateletpheresis unit, not meeting product specifications, was distributed.