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 II Terminated

Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

May 2, 2013 THE COMPOUNDING SHOP, INC. 1 vial of 40ml units
FDA Drug Class II Terminated

Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

May 2, 2013 THE COMPOUNDING SHOP, INC. 19 vials of 10ml units
FDA Drug Class I Terminated

Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ

May 1, 2013 Beamonstar Products 145,632 capsules units
FDA Food Class I Terminated

XYMOGEN EP Exclusive Patented Dietary Supplement Artriphen Clinically Tested to Support Healthy Joint Function, 90 and 180 capsule bottles

May 1, 2013 Atlantic Pro Nutrients, Inc. dba XYMOGEN 16,268 units units
FDA Food Class II Terminated

Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 40802

May 1, 2013 Eastland Food Corporation 210 cases units
NHTSA Ongoing

Unexpected Unfurling of the Awning

May 1, 2013 NEWMAR CORPORATION 111 units
NHTSA Ongoing

Missing Reflectors/FMVSS 108

May 1, 2013 NEWMAR CORPORATION 103 units
FDA Drug Class II Terminated

CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Por

May 1, 2013 Medicis Pharmaceutical Corp 2491 Kits; Expanded 8/29/2013 to include an additional 907 units. units
FDA Drug Class I Terminated

SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ

May 1, 2013 Beamonstar Products 673,851 capsules units
FDA Drug Class III Terminated

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

April 30, 2013 Hi-Tech Pharmacal Co., Inc. lot 608917: 7764 bottles; lot 608204: 7476 bottles units
NHTSA Ongoing

Pressure Release Valve Failure

April 30, 2013 Westmor Industries 510 units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King P

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 112,914 bottles units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 195,201 bottles units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 77,272 bottles units
NHTSA Ongoing

Unexpected Unfurling of the Awning

April 30, 2013 JAYCO, INC. 2,491 units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King P

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 51,591 bottles units
NHTSA Ongoing

Seat Belt Anchor Fittings may be Loose

April 30, 2013 MERCEDES-BENZ USA, LLC. 256 units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 33,227 bottles units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 56,405 bottles units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King P

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 194,142 bottles units
NHTSA Ongoing

Leaking Brake Pressure may Lead to Wheel End Fire

April 30, 2013 HME, Inc. 11 units
FDA Food Class I Terminated

CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand FUDGE BROWNIE COOKIES, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Corner Rt 31 + Rt 93, Lockport, NY 14094 - 716-433-2248 (phone) --- The cookies are pa

April 30, 2013 Carson's Country Market UNKNOWN units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King P

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 195,699 bottles units
FDA Drug Class I Terminated

Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsu

April 30, 2013 American Lifestyle.Com 3 boxes distributed domestically & 4 boxes distributed internationally to consumers. units
FDA Drug Class II Terminated

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32

April 30, 2013 Hospira, Inc. 44,748 bags units
FDA Food Class I Terminated

CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand ASSORTED COOKIE PACK Chocolate Chip - Fudge Brownie - Vanilla Drop - Molasses - Oatmeal Raisin - Peanut Butter - Pumpkin, NET WT. 14 OZ., UPC 7 53182

April 30, 2013 Carson's Country Market UNKNOWN units
FDA Drug Class I Terminated

Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product

April 30, 2013 American Lifestyle.Com 13 boxes distributed domestically & 50 boxes distributed internationally to consumers units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 107,236 bottles units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 103,796 bottles units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King

April 30, 2013 King Legacy, a wholly owned subsidiary of Pfizer 51,438 bottles units
FDA Food Class II Terminated

Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks is a low salt, vacuum packaged, hot smoked salmon. The product is labeled in parts: "***Hot Smoked Atlantic Salmon*** INGREDIENTS: Atlan

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Total 36,105 lbs. for both Cajun Atlantic & Atlantic Garlic & Pepper Chunks units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked Trout and Arctic Char. Clippership products are labeled in parts: "***IMPORTANT. Keep Frozen. Thaw under refrigeration immediately before use***".

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Unknown units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked Salmon (may include any of the following varieties Coho, Keta, King, Sockeye). Jensen's product is labeled in part "*** JENSEN'S SEATTLE STYLE SMOKED WILD PACI

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 14,628 lbs units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked King Nova Salmon. The following is information on the individual products for Alaska King Seafoods brand: All AKS stands for Alaska King Seafoods product lab

April 29, 2013 Jensens Old Fashioned Smokehouse Inc See information under Product #3 -unknown if wild or farmed units
FDA Food Class II Terminated

Jack's Fish Spot Hot Smoked Cajun Atlantic is a low salt, vacuum packaged, Hot Smoked Salmon. This product is labeled in parts: "***Hot Smoked Atlantic Salmon*** INGREDIENTS: Atlantic Salmon, Salt

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Total 36,105 lbs. for both Cajun Atlantic & Atlantic Garlic & Pepper Chunks units
FDA Food Class II Terminated

Hot Smoked Alaskan Sockeye Salmon is a low salt, vacuum packaged. Great Ruby Fish Co Sockeye Hot smoked salmon has no labels. ROLF'S Choice Sockeye Salmon is labeled in parts: "***ROLF'S CHOICE*

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 3,446 lbs. units
FDA Food Class II Terminated

Low salt, vacuum packaged, Garlic Pepper Hot Smoked Salmon with Hardwood. AKS (Alaska King Salmon) product is labeled in parts: "***Garlic Pepper Smoked Salmon product ***GARLIC PEPPER SMOKED SALMO

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Unknown units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked Sturgeon Clippership product is labeled in parts: "***Keep Frozen. Thaw under refrigeration immediately before use***".

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Unknown units
NHTSA Ongoing

Front Lamps Exceed Maximum Brightness/FMVSS 108

April 29, 2013 Toyota Motor Engineering & Manufacturing 208,000 units
FDA Food Class II Terminated

Hot Smoked Pink Salmon is Low salt, vacuum packaged. Clippership Hot Smoked Pink Salmon does not have any labels. Lummi Island Co-Op product's label is read in parts: "***WILD SMOKED PINK SALMON

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 20,271 lbs units
FDA Food Class II Terminated

Short Strips Teriyaki is a low salt, vacuum packaged, Hot Smoked Salmon, and it is sold under Alaska King Seafoods brand. The labels contain the following statement above or below the product name

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 5,615 lbs units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked Halibut was sold under brand Clippership. No product labeling was provided.

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 171 lbs. units
FDA Food Class II Terminated

Great Ruby Fish Co products are such as Keta and King Hot smoked salmon. No labels provided. Products are labeled with lot code sticker and "KEEP FROZEN" sticker on individual units. The customer ap

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 5,125 lbs units
CPSC Ongoing

MTD Products Recalls Cub Cadet Commercial Lawn Mowers Due to Risk of Fire (Recall Alert)

April 29, 2013 MTD Products Inc., of Cleveland, Ohio About 2,100 units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked Farmed Raised Salmon (Atlantic, Coho, Keta, King, Steelhead, and Sockeye). AKS (Alaska King Seafoods) products such as Sockeye Traditional, Coho Traditional,

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Estimated total 45,436 lbs units
FDA Food Class II Terminated

Low salt, vacuum packaged, Hot Smoked Black Cod sold under Clippership. No label was provided.

April 29, 2013 Jensens Old Fashioned Smokehouse Inc Unknown units
FDA Food Class II Terminated

Savory Hot Smoked Salmon is Farmed Raised product, Low salt, vacuum packaged. Savory Smoked Salmon produced by Jensen's Smokehouse is not sold as a vacuum packaged product to the consumer. Product

April 29, 2013 Jensens Old Fashioned Smokehouse Inc 10,971 lbs units
NHTSA Ongoing

Unexpected Unfurling of the Awning

April 29, 2013 THOR MOTOR COACH 427 units
FDA Drug Class III Terminated

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

April 26, 2013 Teva Pharmaceuticals USA, Inc. 758,554 bottles units
NHTSA Ongoing

Unexpected Unfurling of the Awning

April 26, 2013 WINNEBAGO INDUSTRIES, INC. 523 units