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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Made in China Tween Brands Inc Class III Terminated 20131225
Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Tween Brands Inc Class III Terminated 20131225
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8. Taro Pharmaceuticals U.S.A., Inc. Class III Terminated 20131218
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6. Lupin Pharmaceuticals Inc. Class III Terminated 20131218
Volcano Male Enhancement 1500mg, 1-count capsule packaged in a black round plastic pop top container, (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordyceps Sinensis, Go Ji Extract, Superoxide Dismutase). Myson Corporation, Inc. Class I Terminated 20131218
Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0. Myson Corporation, Inc. Class I Terminated 20131218
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216 Boehringer Ingelheim Roxane Inc Class III Terminated 20131218
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50 VistaPharm, Inc. Class II Terminated 20131218
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05 Sandoz Inc Class III Terminated 20131218
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , NDC # 0078-9521-89 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9560-89 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9559-89 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9563-89 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07 Novartis Pharmaceuticals Corp. Class II Terminated 20131218
Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz.. Tube, UPC Code: 634084490145 (US), UPC code: 634084490169 (Canada) W.S. Badger Company Inc. Class II Terminated 20131211
Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada) W.S. Badger Company Inc. Class II Terminated 20131211
Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01 American Health Packaging Class II Terminated 20131211
Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Wydase 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Trypan Blue 0.15% 1ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Tri-Mix SS Pap 30mg, Phen 1mg, PGE1 10mcg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Triamcinolone Diacetate 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211
Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 Main Street Family Pharmacy, LLC Class II Terminated 20131211