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
Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16
January 30, 2013
TG United, Inc.
4,884 - 16 ounce bottles units
FDA Drug
Class II
Terminated
BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737
January 30, 2013
TG United, Inc.
57,936 bottles - 20 mL and 7,476 bottles -16 ounce units
FDA Drug
Class II
Terminated
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
January 30, 2013
TG United, Inc.
10,036 bottles - 100-count tablets units
FDA Drug
Class II
Terminated
AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01
January 30, 2013
TG United, Inc.
886 bottles - 100-count tablets units
FDA Drug
Class II
Terminated
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
January 30, 2013
TG United, Inc.
978,092 Bulk Tablets units
FDA Drug
Class II
Terminated
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-
January 30, 2013
TG United, Inc.
348 - 16 ounce bottles units
NHTSA
Ongoing
Windshield Wipers may not Function Properly
January 30, 2013
ENTEGRA COACH
359 units
FDA Drug
Class II
Terminated
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
January 30, 2013
TG United, Inc.
1398 - 4 ounce bottles units
FDA Drug
Class II
Terminated
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
January 30, 2013
TG United, Inc.
13,031 30 mL bottles. units
NHTSA
Ongoing
Vacuum Pump may Fail/Increased Stopping Distances
January 30, 2013
MITSUBISHI MOTORS NORTH AMERICA, INC.
1,402 units
FDA Drug
Class II
Terminated
AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
January 30, 2013
TG United, Inc.
348 - 16 ounce bottles units
FDA Drug
Class II
Terminated
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
January 30, 2013
TG United, Inc.
39,403 - 30 mL bottles units
FDA Drug
Class II
Terminated
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
January 30, 2013
TG United, Inc.
242,470 units
FDA Food
Class II
Terminated
Z Pro 25 High Protein Supplement Net. Wt. 1.5 oz. - Chocolate Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110
January 30, 2013
R-Kane Products Inc.
N/A units
FDA Drug
Class II
Terminated
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
January 30, 2013
TG United, Inc.
977,719 Bulk Tablets units
CPSC
Ongoing
Million Dollar Baby Dressers Recalled by Bexco Due to Tip-Over Hazards; Two Toddler Deaths Reported
January 30, 2013
18000 units
FDA Drug
Class II
Terminated
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
January 30, 2013
TG United, Inc.
216,838 bottles - 30 mL units
CPSC
Ongoing
Natart Chelsea Dressers Recalled By Gemme Juvenile To Reduce Tip-Over Hazard; Death of Toddler Reported
January 30, 2013
Gemme Juvenile Inc., of Princeville, Quebec, Canada
About 300 units
FDA Drug
Class II
Terminated
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
January 30, 2013
TG United, Inc.
39,801 - 30 mL bottles. units
FDA Drug
Class II
Terminated
NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01
January 30, 2013
TG United, Inc.
4824 bottles - 100-count units
FDA Drug
Class II
Terminated
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
January 30, 2013
TG United, Inc.
1623 bottles of 100-count tablets. units
CPSC
Ongoing
Sportspower Expands Trampoline Recall Due to Fall Hazard; Sold Exclusively at Walmart
January 30, 2013
Sportspower Ltd., of Hong Kong
About 120,000 (92,000 units were recalled in May 2012) units
FDA Drug
Class II
Terminated
AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16
January 30, 2013
TG United, Inc.
352 - 16 ounce bottles units
FDA Drug
Class II
Terminated
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
January 30, 2013
TG United, Inc.
4811 - 16 ounce bottles. units
FDA Drug
Class II
Terminated
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
January 30, 2013
TG United, Inc.
1772 bottles per 100 count each units
FDA Drug
Class II
Terminated
AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-
January 30, 2013
TG United, Inc.
348 - 16 ounce bottles units
FDA Drug
Class II
Terminated
Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30
January 30, 2013
TG United, Inc.
26,536 bottles - 30 mL units
FDA Drug
Class II
Terminated
Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16
January 30, 2013
TG United, Inc.
12,198 - 16 ounce bottles. units
FDA Drug
Class II
Terminated
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
January 30, 2013
TG United, Inc.
2388 - 16 ounce bottles. units
FDA Drug
Class II
Terminated
TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16
January 30, 2013
TG United, Inc.
98,202 16 ounce bottles. units
CPSC
Ongoing
Columbia Sportswear Recalls Seven Models of Heated Jackets Due To Burn Hazard
January 29, 2013
About 9,600 in the U.S. and 640 in Canada units
CPSC
Ongoing
BRP Recalls Can-Am Side-By-Side Vehicles Due to Fire Hazard
January 29, 2013
BRP Mexico S.A. de C.V., of Juarez, Chihuahua, Mexico
About 25,000 units
FDA Food
Class I
Terminated
Cream cheese/cold smoked salmon (Gravlox) spread in plastic containers. A sample of product label (SELL BY and PACK DATES may differ): "0295307 014144 LOX & CREAM CHEESE WHOLE FOODS MARKET CCOLD
January 29, 2013
Whole Foods Market Pacific NW Distribution Center (PDC)
Distributed to14 Whole Foods Markets in WA and OR. Amounts pending. units
FDA Food
Class I
Terminated
Whole bagels and half bagels w/ cream cheese/cold smoked salmon spread wrapped in plastic. An example of the whole bagel label (in part): "0298437 003996 BAGEL FULL LOX CREAM CHEESE CAPERS BAGEL
January 29, 2013
Whole Foods Market Pacific NW Distribution Center (PDC)
Distributed to14 Whole Foods Markets in WA and OR. Amounts pending units
NHTSA
Ongoing
Aluminum Wheel Fractures
January 29, 2013
Vision Wheel, Inc.
3,143 units
FDA Food
Class I
Terminated
Cold-smoked salmon in plastic containers. An example of the labeling follows, however, the "SELL BY:" and "PACK DATE" changes. "0297629 015885 SOCKEYE SALMON LOX TRIM WHOLE FOODS MARKET SALMON, SA
January 29, 2013
Whole Foods Market Pacific NW Distribution Center (PDC)
Distributed to 14 Whole Foods Market stores in WA and OR. Amounts pending. units
FDA Food
Class I
Terminated
Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced
January 29, 2013
Ocean Beauty Seafoods, LLC
336 pounds (2 pound packages) units
NHTSA
Ongoing
Rear Suspension may Re-inflate with Key-off
January 29, 2013
PACCAR, INCORPORATED
330 units
NHTSA
Ongoing
Steel Wheel Separation
January 29, 2013
Maxion Wheels/Hayes Lemmerz
732 units
FDA Food
Class I
Terminated
Brocco sprouts is broccoli sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The Brocco sprouts, 4oz., distributed BRASSICA, has UPC 8 15098 00025; The Brocco sprouts, 85 gram
January 28, 2013
Giant Greens, Inc.
792/4 oz. Packages and 528/85 g. Packages units
FDA Food
Class I
Terminated
Mung Bean sprouts is packaged in a 8 oz clamshell container or 5 lb. bag and sold under the Sprouters Northwest or Life Force brand. The Life Force foods, 8 oz, has UPC 8 15098 00107 1; The Spr
January 28, 2013
Giant Greens, Inc.
33774/8 oz. Packages and 416/5 lb. Bags units
NHTSA
Ongoing
Iota Transfer Switch Overheating
January 28, 2013
DUTCHMEN MANUFACTURING, INC.
698 units
FDA Food
Class I
Terminated
Clover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray. Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC
January 28, 2013
Giant Greens, Inc.
14154/4 oz. Packages; 5130/5 oz. Packages; 24287/1 lb. Bags; and 552/2 lb. Trays units
FDA Food
Class II
Terminated
Wheatgrass is packaged in a pint or cup, 16 oz. bag, or 5 lb. Flat cardboard box and sold under the Sprouters Northwest brand. The Wheatgrass in a pint or cup has UPC 0 79566 12380 5; The wheatgr
January 28, 2013
Giant Greens, Inc.
3024/1 pint Packages; 888 cups; 63/16 oz. Bags; and 494/5 lbs. Flat boxes; units
FDA Food
Class I
Terminated
Spicy Sprouts, packaged in a 4 oz. clamshell container or 85 gram package. The product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4 oz., has UPC is 8 15098 0020
January 28, 2013
Giant Greens, Inc.
7212/4 oz. Packages and 420/85 gram Packages. units
FDA Food
Class II
Terminated
Organic Pea Shoots are packaged in a 3 oz. or 4 oz packages. Product is sold under the Life Force or Trader Joe's brand. The Life Force, 3 oz, has UPC 8 51042 00414 9. The Trader Joe's, 4 oz, h
January 28, 2013
Giant Greens, Inc.
390/3 oz. Packages and 3180/4 oz. Packages units
FDA Food
Class I
Terminated
3 Bean Munchies sprouts is a mixture of Green Peas, Cow Peas, Red Lentils and Garbanzo Beans. Product is packaged in a 4 oz clamshell container and sold under the Sprouters Northwest brand. Product
January 28, 2013
Giant Greens, Inc.
1146/4 oz Packages units
FDA Food
Class I
Terminated
Brocco Sprouts Sandwich Blend, packaged in a 4 oz. clamshell container, the UPC is 8 15098 00028 9. The product is labeled in parts: "***BROCCO SPROUTS SANDWICH BLEND***broccoli & clover sprouts**
January 28, 2013
Giant Greens, Inc.
2306/4 oz. Packages units
FDA Drug
Class III
Terminated
Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.
January 28, 2013
Stat Rx USA
3 bottles units
FDA Food
Class I
Terminated
Cucumbers, 44 lbs/box. Brand: Malichita (green, yellow, red and white background color on each cartons)
January 28, 2013
Altiza Inc.
343 units units