Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

NHTSA Ongoing

Lug Nuts may not Secure Wheel

September 6, 2019 TAP Worldwide, LLC 840 units
FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35

September 6, 2019 Mylan Pharmaceuticals Inc. 13,157 5 mL bottles units
FDA Food Class II Terminated

Udi's Classic Hamburger Buns, packaged in a 10.4 oz. plastic bag, with eight bags per wholesale case. UPC 00-6-98997-80913-5 .

September 6, 2019 ConAgra Foods Inc 2205 cases units
FDA Drug Class II Terminated

Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03

September 6, 2019 Pfizer Inc. 185,700 vials units
FDA Drug Class I Terminated

Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 3270

September 6, 2019 Darmerica, LLC 1.8 kilograms units
FDA Drug Class III Terminated

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc

September 6, 2019 Teva Pharmaceuticals USA 5,849 bottles units
FDA Food Class II Terminated

Alfa International Seafood Miami, Fl, 8402, Yellowfin Tuna Loins, Previously Frozen, Wild Caught, Product of Vietnam

September 6, 2019 ALFA INTERNATIONAL SEAFOOD INC 8,585.99 pounds units
FDA Drug Class II Terminated

Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.

September 6, 2019 Torrent Pharma Inc 2472 bottles units
FDA Food Class II Terminated

Silk Soymilk Vanilla Bag-In-Box. One, 2.5 gallon bag per box. 2.5 gal Bag-In-Box to be used in a dispensing machine at foodservice & convenience outlets.

September 5, 2019 DANONE 46 Cases units
CPSC Ongoing

Walker Edison Furniture Recalls Children's Bunk Beds Due to Fall and Injury Hazards (Recall Alert)

September 5, 2019 About 1,200 (in addition, about 26 were sold in Canada) units
CPSC Ongoing

STIHL PolyCut Mowing Heads Recalled Due to Injury Hazard

September 5, 2019 STIHL Incorporated, of Virginia Beach, VA About 73,000 units
CPSC Ongoing

MW Company Recalls MOMO Quick Release Steering Wheel Adapters Due to Crash Hazard; Risk of Serious Injury and Death

September 5, 2019 About 260 units
CPSC Ongoing

John Deere Recalls Frontier Grooming Mowers Due to Entanglement Injury Hazard (Recall Alert)

September 4, 2019 Manufactured for Frontier, a brand name of Deere & Company, by Woods Equipment Company of Oregon, Ill. About 730 (in addition, about 20 were sold in Canada) units
FDA Drug Class II Terminated

Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceut

September 4, 2019 Jubilant Cadista Pharmaceuticals Inc. 63,216 bottles units
CPSC Ongoing

Kawasaki USA Recalls Recreational Off-Highway Vehicles Due to Crash and Injury Hazards (Recall Alert)

September 4, 2019 Kawasaki Motors Manufacturing Corp. U.S.A., Lincoln, Neb. About 2,600 units
CPSC Ongoing

Gator Utility Vehicles Recalled by John Deere Due to Crash Hazard (Recall Alert)

September 4, 2019 Deere & Company, of Moline, Ill. About 19,730 (In addition, about 840 were sold in Canada) units
CPSC Ongoing

Artizen Oils Recalls Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements, Risk of Poisoning

September 4, 2019 Artizen Oils LLC, of Denver, Colo. About 6,000 units
FDA Food Class II Terminated

Ore Ida Spud Bites, packaged in 5lb. plain poly foodservice bags, six bags per case, frozen, Case UPC: 1 00 72714 00093 2. SKU: OIF00093A

September 4, 2019 McCain Foods USA 2,830 cases units
FDA Food Class III Terminated

365 Everyday Value Organic Instant Oatmeal Maple and Brown Sugar Pecan With Other Natural Flavors UPC 9948247977 NET WT 2.3 OZ. microwaveable cups cold individually

September 4, 2019 Whole Foods Market 11,520 units units
FDA Drug Class II Terminated

5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

September 3, 2019 Compounded Solutions in Pharmacy a) 4x5 ml, b) 1x10 ml bottles units
FDA Drug Class II Terminated

Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.

September 3, 2019 Compounded Solutions in Pharmacy 3x3 ml dropper bottles units
FDA Drug Class II Terminated

Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health 17 vials units
NHTSA Ongoing

Upper Bunk May Collapse

September 3, 2019 FOREST RIVER, INC. 41 units
FDA Drug Class II Terminated

Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Food Class I Terminated

TAINY VOSTOKA DRY FRUIT MIX QUINCE COMPOTE 17.65oz (500 gram); Container code# 27032019; UPC code 4605932006203.

September 3, 2019 Euroline Foods LLC 260 pieces (13 cases with 20 pieces each) units
FDA Drug Class II Terminated

Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
CPSC Ongoing

The Beaufort Bonnet Company Recalls Handmade Knit Dolls Due to Injury Hazard

September 3, 2019 About 4,500 units
FDA Drug Class II Terminated

Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units
FDA Drug Class II Terminated

Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

September 3, 2019 Coast Quality Pharmacy, LLC dba Anazao Health Unknown units