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