Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

CPSC Ongoing

Manhattan Toy Recalls Toy Planes Due to Choking Hazard

August 23, 2018 About 5,100 (In addition, about 930 were sold in Canada) units
NHTSA Ongoing

Alternator and Starter Cables may be Loose

August 23, 2018 FORD MOTOR COMPANY 87 units
FDA Drug Class I Terminated

Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02

August 23, 2018 Hellolife 370 bottles units
FDA Drug Class I Terminated

Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02

August 23, 2018 Hellolife 4,358 bottles units
FDA Drug Class II Terminated

Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

August 23, 2018 Pacific Compounding Pharmacy & Consultations Inc 41.4 mL units
FDA Food Class II Terminated

Dewey's BAKERY Soft Baked TRIPLE CHOCOLATE BROWNIE COOKIES NET WT. 6 OZ paper bag Dewey's BAKERY WINSTON-SALEM, NC 27103 (877) 339-3974 UPC 7 63027 21022 6

August 23, 2018 Dewey's Bakery, Inc dba Salem Baking Company 33,473/6 oz bags units
NHTSA Ongoing

Break-Away Safety Switch may be Improperly Wired

August 22, 2018 FOREST RIVER, INC. 69 units
CPSC Ongoing

Vornado Air Reannounces Recall of Electric Space Heaters Following Report of Death; Fire and Burn Hazards

August 22, 2018 About 350,000 (This recall was first announced in April 2018) units
FDA Drug Class II Terminated

THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient;

August 22, 2018 Syntec Pharma Corp 2 drums units
CPSC Ongoing

Yamaha Recalls Snowmobiles Due to Injury Hazard (Recall Alert)

August 22, 2018 About 120 units
NHTSA Ongoing

Cabinet Mirror Over Driver Seat may Fall

August 22, 2018 WINNEBAGO INDUSTRIES, INC. 1,066 units
FDA Drug Class II Terminated

THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx C

August 22, 2018 Syntec Pharma Corp 486 kg units
NHTSA Ongoing

Trailer may Separate from Fifth Wheel

August 22, 2018 MACK TRUCKS, INC 9 units
NHTSA Ongoing

Solar Charging Port Circuit is not Fused

August 22, 2018 WINNEBAGO INDUSTRIES, INC. 6,700 units
FDA Drug Class II Terminated

Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 81 vials units
FDA Drug Class II Terminated

CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 39 vials units
FDA Drug Class II Terminated

Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 91 vials units
CPSC Ongoing

Confer Plastics Recalls Pool Step Systems Due to Entrapment and Drowning Hazard

August 21, 2018 Confer Plastics, of North Tonawanda, N.Y. About 100,000 (In addition, about 2,100 were sold in Canada) units
FDA Drug Class II Terminated

Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 11 vials units
FDA Drug Class II Terminated

Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/22

August 21, 2018 Sichuan Friendly Pharmaceutical Co.,Ltd. 2662 kg units
FDA Drug Class II Terminated

Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 74 vials units
NHTSA Ongoing

Insufficient Coating on Rear Brake Caliper Pistons

August 21, 2018 MERCEDES-BENZ USA, LLC. 9,044 units
FDA Drug Class II Terminated

Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 183 vials units
FDA Drug Class II Terminated

Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 40 vials units
FDA Drug Class II Terminated

Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 114 vials units
NHTSA Ongoing

Incorrect Tire Information on Federal Cert Label

August 21, 2018 KZRV, L.P. 1,160 units
NHTSA Ongoing

Trailer may Separate from Fifth Wheel

August 21, 2018 VOLVO TRUCKS NORTH AMERICA 69 units
NHTSA Ongoing

Vehicle May Move if Parked on a Grade

August 21, 2018 Spartan Motors USA 274 units
FDA Drug Class II Terminated

Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 32 vials units
FDA Drug Class II Terminated

Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 90 vials units
FDA Food Class II Terminated

Premo Brand Turkey & Cheese Wedge sandwiches 5 OZ retail UPC 612510002018 Plastic triangle sandwich wedge container with plastic film. Refrigerated. 4, 5 OZ retail units per wholesale case.

August 21, 2018 Lipari Foods Operating Company, LLC dba JLM Manufacturing 3,448 retail units units
FDA Drug Class II Terminated

Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 43 vials units
FDA Drug Class II Terminated

0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18

August 21, 2018 Baxter Healthcare Corporation 33600 bags units
FDA Drug Class II Terminated

Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

August 21, 2018 Auro Pharmacies, Inc. 167 vials units
NHTSA Ongoing

Reduced Clearance Light Visibility/FMVSS 108

August 21, 2018 SUPREME CORPORATION 440 units
FDA Drug Class I Terminated

Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, I

August 21, 2018 Accord Healthcare, Inc. 46,632 bottles units
FDA Drug Class III Terminated

Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.

August 21, 2018 Mayne Pharma Inc 6456 bottles units
FDA Drug Class II Terminated

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals

August 20, 2018 Hetero Labs Limited Unit V 98,016 bottles units
FDA Drug Class II Terminated

Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0

August 20, 2018 RemedyRepack Inc. 3 bottles of 90 tablets (270 tablets overall) units
NHTSA Ongoing

Passenger Air Bag Incorrectly Manufactured

August 20, 2018 BMW OF NORTH AMERICA, LLC 3 units
NHTSA Ongoing

Brake Caliper Bracket Bolts may be Loose

August 20, 2018 Volkswagen Group of America, Inc. 8,416 units
FDA Food Class II Terminated

Mexican Style Ricotta Cheese labeled, "Don Froylan Requeson***Mexican Style Ricotta Cheese***Ingredients: Pasteurized Whey, Salt***" 1lb. (16 oz.) and bulk plastic bags in 2lb. and 5lb.

August 20, 2018 Ochoa's Queseria LLC 1357 total units (1330 units of 1 lb.; 3 bags of 5lb (15 units); 6 bags of 2lb (12 units)) units
NHTSA Ongoing

A/C Drain Tube Causing Air Bag Malfunction

August 20, 2018 Volkswagen Group of America, Inc. 9,685 units
NHTSA Ongoing

Countertop may cause Burns after Oven Use

August 20, 2018 FOREST RIVER, INC. 22 units
NHTSA Ongoing

Missing Rear Seat back Lock Strikers

August 20, 2018 Volvo Car USA LLC 27 units
FDA Food Class I Terminated

Salad Mix (Green Kale, Green Cabbage, Broccoli Stems, Chicory, and Brussel Sprouts)

August 18, 2018 Air Stream Corp. 887 Cases (total for all products) units
FDA Food Class II Terminated

Radicchio, 10 lbs

August 18, 2018 Air Stream Corp. 887 cases (total for all products) units
FDA Food Class I Terminated

Salad Mix (Endive, Chicory, Romaine, Escarole, and Radicchio)

August 18, 2018 Air Stream Corp. 887 cases (total for all products) units
FDA Food Class II Terminated

Shredded green cabbage

August 18, 2018 Air Stream Corp. 887 cases (total for all products) units
FDA Food Class II Terminated

Green Kale

August 18, 2018 Air Stream Corp. 887 cases (total for all products) units