Product Recalls in 2013
5,503 recalls issued this year
290
CPSC
2,420
FDA Food
2,085
FDA Drug
708
NHTSA
FDA Food
Class II
Terminated
Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
October 14, 2013
Innovative Labs, LLC
1256 bottles units
FDA Food
Class II
Terminated
Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle. Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
October 14, 2013
Innovative Labs, LLC
579 bottles units
FDA Drug
Class II
Terminated
Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus¿¿ labels. NDC 0703-5
October 11, 2013
Teva Pharmaceuticals USA
13520 vials units
FDA Food
Class II
Terminated
Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
October 11, 2013
Metagenics, Inc.
1,171,300 units units
FDA Drug
Class II
Terminated
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
October 11, 2013
Hospira, Inc.
70,450 vials units
FDA Food
Class II
Terminated
Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO HUMAN MILK - DO NOT ADD WATER NET WT 0.031 OZ (0.90g)***CONTAINS MILK AND SOY INGR
October 11, 2013
Abbott Nutrition
Lot # L31056Z200-249cs/3 ctns/50/0.9 oz packets; Lot L27385Z200-328 cs/3 ctns/50/0.9 oz packets & Lot L30698Z200-349 cs/3 ctns/50/0.9 oz packets. units
FDA Drug
Class II
Terminated
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
October 11, 2013
Hospira, Inc.
65109 vials units
FDA Food
Class I
Terminated
PRAN TURMERIC POWDER 400 GM plastic bag
October 11, 2013
Best Value Inc
10 boxes (20 bags/box) units
FDA Food
Class I
Terminated
Custom made gift boxes containing: HONEY ROASTED PEANUTS, Net Wt. 11 oz. (311G), Dist.By: Dutch Valley Food Distributors, Inc. Myerstown, PA 10787, UPC 8 77245 00143 3
October 11, 2013
yoders country market
24 units units
FDA Drug
Class II
Terminated
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
October 11, 2013
Sandoz, Inc
2,491 bottles of 100 tablets each units
FDA Drug
Class I
Terminated
Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
October 10, 2013
Pure Edge Nutrition
unknown units
FDA Drug
Class I
Terminated
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
October 10, 2013
Pure Edge Nutrition
unknown units
FDA Drug
Class I
Terminated
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
October 10, 2013
Pure Edge Nutrition
unknown units
FDA Drug
Class II
Terminated
Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Radnor PA 19087 Distributed by Keene Medical Products, 240 Meridian Road, NH 03766. NDC 11054-009
October 10, 2013
Airgas Medical Services
145 cylinders units
FDA Food
Class II
Terminated
Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521
October 10, 2013
ProThera, Inc.
27,480 units
FDA Food
Class I
Terminated
the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Distributed by Safeway, Inc. Pleasanton, CA 94566
October 10, 2013
Barrel O' Fun Snack Foods Co.
3 cases (12-10 oz. bags per case) units
FDA Drug
Class I
Terminated
Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
October 10, 2013
Pure Edge Nutrition
unknown units
FDA Food
Class II
Terminated
Klaire Labs Vital-Zymes complete; Comprehensive Enzyme Supplement; 120 Vegetarian tablets. UPC 790616310005 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89
October 10, 2013
ProThera, Inc.
187,941 lot 0613110; 491.232 lot 0513156 and 504864 lot 0513157 units
FDA Food
Class II
Terminated
Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , K
October 10, 2013
ProThera, Inc.
243,851 units
FDA Drug
Class I
Terminated
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
October 10, 2013
Pure Edge Nutrition
unknown units
FDA Food
Class II
Terminated
Klaire Labs Interfase Plus; Enzyme Supplement; 120 Vegetarian capsules bottles. UPC 7 09616 01228 4 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521 N
October 10, 2013
ProThera, Inc.
FDA Drug
Class I
Terminated
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
October 10, 2013
Pure Edge Nutrition
unknown units
FDA Food
Class II
Terminated
Total Probiotics, Dietary Supplement, Nutri-West, 50 Capsules, Servicing Size 1 Capsule
October 10, 2013
Nutrition Center, Inc. dba Nutri-West
13,864 bottles units
FDA Food
Class II
Terminated
Total Enzyme, Dietary Supplement, Nutri-West, 120 capsules, Servicing Size 1 Capsule
October 10, 2013
Nutrition Center, Inc. dba Nutri-West
8,414 bottles units
FDA Food
Class II
Terminated
Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89
October 10, 2013
ProThera, Inc.
82,746 lot F3990 and 988.200 of lot C3516. units
FDA Drug
Class II
Terminated
Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
October 9, 2013
Sandoz, Inc
692 bottles (90 count) units
FDA Drug
Class II
Terminated
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
October 9, 2013
Actavis Elizabeth LLC
756 bottles units
FDA Food
Class II
Terminated
White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
October 8, 2013
Quaker Foods and Snacks North America
2,720 cases (32,640 bags) units
FDA Food
Class I
Terminated
PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Ba
October 8, 2013
Asia Cash & Carry Inc.
10 cartons units
FDA Food
Class II
Terminated
Good Sense Spicy Sweet Mix, 25-oz (1lb 9oz) plastic container, UPC: 030243787178
October 8, 2013
Krispak Inc
315 cases (1890 units) units
FDA Food
Class II
Terminated
White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
October 8, 2013
Quaker Foods and Snacks North America
2,720 cases (32,640 bags) units
FDA Drug
Class II
Terminated
Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals,
October 7, 2013
Amedra Pharmaceuticals LLC
10,992 bottles units
FDA Food
Class II
Terminated
Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072
October 7, 2013
Kellogg Canada Corporate Office
182, 000 cases of 14 units units
FDA Food
Class II
Terminated
Beachbody Optimize Enzymes Capusles, 126 CT, 8 oz. Container size: JAR 8OZ WHITE 70MM NECK POLYPROPYLENE 126 capsules per bottle. Product labeling
October 7, 2013
Cgnp Manufacturing
500 bottles units
FDA Drug
Class I
Terminated
Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.
October 7, 2013
B @ B Trade Inc.
10 bottles units
FDA Drug
Class II
Terminated
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D
October 7, 2013
Betachem, Inc.
27,000 kilos (1080 drums) units
FDA Food
Class II
Terminated
Beach Body Ultimate Reset Kit 2.0( each Kit consist of 1 bottle of the above optimize enzymes capsules product and 5 bottles of additional product) Product labeling reads in part:
October 7, 2013
Cgnp Manufacturing
6,152 kits units
FDA Drug
Class I
Terminated
Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
October 7, 2013
B @ B Trade Inc.
10 bottles units
FDA Drug
Class I
Terminated
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
October 7, 2013
B @ B Trade Inc.
10 bottles units
FDA Food
Class I
Terminated
Red and Green Bell Peppers, 25 lbs.
October 6, 2013
Orange County Produce
1208 units units
FDA Food
Class I
Terminated
Reser's Fine Foods, Cheesy Macaroni Salad, packaged in 454 gm (UPC 071117182415) and 1.25 KG (UPC 071117612271) plastic containers.
October 5, 2013
Reser's Fine Foods, Inc.
279 cases (138/12/454 -gm container/cases and 141/6/1.25-KG container/cases) units
FDA Food
Class II
Terminated
VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 48. National Distributors: V.E. Irons, Inc, N. Kansas City, MO. Sprin
October 4, 2013
Vitalab Co Inc
280 bottles units
FDA Food
Class II
Terminated
10 inch Apple Pie (baked and unbaked), NET WT 42 oz.(2 lb 10 oz), UPC 41735-22064 (unbaked) and 41735-23712 (baked), Price Chopper label.
October 4, 2013
Price Chopper Supermarkets
96 pies were shipped to the stores but only 6 affected pies were sold units
FDA Food
Class II
Terminated
Digestive Health, 90 vegetable capsules
October 4, 2013
Ultra Laboratories
2,200 bottles units
FDA Food
Class II
Terminated
Turkey Hill Stuff'd Moose Tracks Frozen Dairy Dessert Size: 1 Pint (473 ml), packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
October 4, 2013
Turkey Hill Dairy, Inc.
4440 pints units
FDA Food
Class II
Terminated
Turkey Hill Premium Chocolate Peanut Butter Cup Ice Cream Size 1 Pint (473 ml) packaged in a paper cup and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
October 4, 2013
Turkey Hill Dairy, Inc.
232 units
FDA Food
Class II
Terminated
Turkey Hill Pumpkin Pie Premium Ice Cream 48 oz. packaged in a paper tub and lid, distributed by Turkey Hill Dairy, Conestoga, PA.
October 4, 2013
Turkey Hill Dairy, Inc.
756 tubs units
FDA Food
Class II
Terminated
Protease: APEX 10-7082 CENTURY 7-152 EB 2-14511 EB 5-16901 EB 8-14861 EB 9-14191 EXCLZYME EXCLZYME EN GLOBAL 8-658 HFN 7-7113 META 10-185 MHNHEM 2-158 PEPZYME AG PROTEASE - 1000 PROTE
October 3, 2013
Specialty Enzymes & Biotechnologies
5,780 kg units
FDA Food
Class II
Terminated
Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIG
October 3, 2013
Specialty Enzymes & Biotechnologies
33247.5kg units
FDA Food
Class I
Terminated
PRAN brand Spice Powder TURMERIC, Net Wt. 14.1 oz./400g, UPC 8 46656 00209 4, and Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PR
October 3, 2013
Ontime Distribution Inc.
18 - 250 gram jars and 23 - 400 gram jars units