Product Recalls in 2013

5,503 recalls issued this year

290

CPSC

2,420

FDA Food

2,085

FDA Drug

708

NHTSA

FDA Drug Class III Terminated

buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Dis

February 4, 2013 American Health Packaging 389 cartons units
NHTSA Ongoing

Fuel Pump Assembly Failure/Possible Engine Stall

February 4, 2013 YAMAHA MOTOR CORPORATION, USA 8,700 units
FDA Drug Class II Terminated

Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP

February 4, 2013 Carib Import & Export, Inc. 480 bottles units
FDA Food Class I Terminated

GREEN DAY DRIED COCONUT, Net Wt: 3oz (85g), UPC bar code 6 950296 800744 -- Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. -- Add: Donggua Hill, Beitou Village, Qibao, Xinhui District, Jiangmen

February 4, 2013 Domega NY International Co Ltd 71 cases total ( 50 x 85 gm packages per case) units
FDA Food Class II Terminated

SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600

February 4, 2013 Aptalis Pharma Us Inc 14439 units units
FDA Food Class I Terminated

GoldCoast Salads Marine Lobster Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)

February 1, 2013 GoldCoast Salads 6,919 cases total units
FDA Drug Class III Terminated

TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960

February 1, 2013 Ferring Pharmaceuticals Inc 126 injectors units
NHTSA Ongoing

Plastic Lift Deck Guides may Fail

February 1, 2013 WILSON TRAILER COMPANY 556 units
FDA Food Class I Terminated

GoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)

February 1, 2013 GoldCoast Salads 6,857 cases total units
NHTSA Ongoing

Oil Filter Leak

February 1, 2013 Fram Group Operatons, LLC 282,514 units
FDA Food Class I Terminated

GoldCoast Salads Smoked Salmon Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)

February 1, 2013 GoldCoast Salads 1,567 cases Total units
FDA Drug Class III Terminated

CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, N

February 1, 2013 Fresenius Kabi USA LLC (FK USA) 155,900 vials domestically units
FDA Food Class I Terminated

GoldCoast Salads Lobster & Shrimp Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below)

February 1, 2013 GoldCoast Salads 2,284 cases total units
FDA Drug Class II Terminated

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC

January 31, 2013 Noven Pharmaceuticals, Inc. 335,910 patches units
CPSC Ongoing

Triaminic and Theraflu Products Recalled Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning

January 31, 2013 Novartis Consumer Health Inc., of Parsippany, NJ About 2.3 Million units
CPSC Ongoing

Kringles Toys and Gifts Recalls High Powered Magnets Due to Ingestion Hazard; Sold Exclusively on Amazon.com

January 31, 2013 Kringle Toys and Gifts, of American Fork, Utah About 4,200 units
CPSC Ongoing

High Powered Magnet Balls Recalled by SCS Direct Due to Risk of Ingestion; Sold Exclusively on Amazon.com

January 31, 2013 SCS Direct Inc., of Stratford, Conn. About 106,000 units
NHTSA Ongoing

Wheel Bearings may Fail Prematurely

January 31, 2013 TRIUMPH MOTORCYCLES (AMERICA) LTD 250 units
FDA Drug Class III Terminated

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by

January 31, 2013 Lupin Pharmaceuticals Inc. 64,368 bottles units
CPSC Ongoing

FoodState Recalls Bottles of MegaFood One Daily Supplements Due to Lack of Child-Resistant Packaging

January 31, 2013 FoodState Inc., of Derry, N.H. About 7,400 units units
NHTSA Ongoing

Improper Weld may cause Bar to Fail

January 31, 2013 Rigid Hitch Inc. 352 units
FDA Food Class II Terminated

Canned mushrooms, #10 cans (Brites, not labeled)

January 31, 2013 L. K. Bowman, Incorporated 3,480 units
FDA Drug Class I Terminated

Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.

January 31, 2013 Gilead Sciences, Inc. 3,181 vials units
CPSC Ongoing

World Imports Recalls Bunk Beds Due to Violation of Safety Standard

January 31, 2013 Zhangzhou Sanchuan Steel Pipe Goods Co., Ltd., of China About 8,600 units
FDA Drug Class II Terminated

CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30

January 30, 2013 TG United, Inc. 6551 30 mL bottles units
FDA Drug Class II Terminated

CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30

January 30, 2013 TG United, Inc. 26,315 - 30 mL bottles. units
FDA Drug Class II Terminated

AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles. units
FDA Drug Class II Terminated

BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16

January 30, 2013 TG United, Inc. 22,721 - 16 ounce bottles units
NHTSA Ongoing

Wiper Arm May Loosen

January 30, 2013 Toyota Motor Engineering & Manufacturing 267,718 units
FDA Drug Class II Terminated

Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01

January 30, 2013 TG United, Inc. 31,739 bottles 100-count; 842,617 Bulk tablet bottles units
FDA Drug Class II Terminated

Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16

January 30, 2013 TG United, Inc. 12,120 - 16 ounce bottles units
FDA Drug Class II Terminated

Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30

January 30, 2013 TG United, Inc. 12,988 - 30 mL bottles. units
FDA Drug Class II Terminated

AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles. units
FDA Drug Class II Terminated

Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

January 30, 2013 TG United, Inc. 40,149 - 30 mL bottles. units
FDA Drug Class II Terminated

BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

January 30, 2013 TG United, Inc. 16,836 bottles - 100-count. units
FDA Drug Class II Terminated

Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05.

January 30, 2013 Mylan Pharmaceuticals Inc. 1,894 bottles units
FDA Drug Class II Terminated

TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10

January 30, 2013 TG United, Inc. 386 - 1000-count bottles units
FDA Drug Class II Terminated

Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10

January 30, 2013 TG United, Inc. 2957 bottles 100-count tablets units
FDA Food Class II Terminated

Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110

January 30, 2013 R-Kane Products Inc. unavailable units
FDA Drug Class II Terminated

Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

January 30, 2013 TG United, Inc. 330158 Bulk tablets. units
FDA Drug Class II Terminated

AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0

January 30, 2013 TG United, Inc. 348 - 16 ounce bottles units
FDA Drug Class II Terminated

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

January 30, 2013 TG United, Inc. 2706 bottles of 100 count tablets units
FDA Drug Class II Terminated

TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

January 30, 2013 TG United, Inc. 2532 - 16 ounce bottles. units
FDA Drug Class II Terminated

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

January 30, 2013 TG United, Inc. 8296 bottles - 100-count and 153,028 Bulk tablets units
FDA Drug Class II Terminated

BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

January 30, 2013 TG United, Inc. 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce. units
FDA Food Class II Terminated

A soft chevre-style cheese. Label reads in part, "*** TUMALO FARMS Artisan Cheeses of Central Oregon Chevita This fresh and mild, soft, white cheese has a great tangy finish www.tumalofarms.com *** I

January 30, 2013 Tumalo Farms LLC From production date 1/10/13 10 - 4 oz tubs and 4-2 lb tubs; from production date 1/24/13 3 4 oz tubs and 8 2 lb tubs units
FDA Drug Class II Terminated

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

January 30, 2013 TG United, Inc. 355 - 16 ounce bottles units
NHTSA Ongoing

Airbag Inadvertent Deployment

January 30, 2013 Toyota Motor Engineering & Manufacturing 887,709 units
FDA Drug Class II Terminated

Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

January 30, 2013 TG United, Inc. N/A units
FDA Food Class II Terminated

A soft brie-style cheese called Jewell. Ingredients: Certified organic cows' milk, Pasteurized farmstead goats' milk, cultures, rennet and salt. (information obtained from firm's web site)

January 30, 2013 Tumalo Farms LLC 222 - 6 oz pucks units