Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class IMeizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class ISlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class IPill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class ISuper Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class IFruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class IJIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
- 2014-06-18FDA-DrugMyNicNaxs, Inc.Class IREDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
- 2014-06-18FDA-DrugPure Edge NutritionClass IBella 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
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- 2014-06-18FDA-DrugPure Edge NutritionClass IBella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- 2014-06-18FDA-DrugPure Edge NutritionClass IBella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- 2014-06-18FDA-DrugPure Edge NutritionClass IBella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- 2014-06-18FDA-DrugPure Edge NutritionClass IBella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- 2014-06-18FDA-DrugPure Edge NutritionClass IBella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- 2014-06-18FDA-DrugVitality Research Labs LLCClass IvitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
- 2014-06-18FDA-DrugLegacy Pharmaceutical PackagingClass IIPantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
- 2014-06-18FDA-DrugPharmakon PharmaceuticalsClass IMidazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
Superpotent Drug: Product contains twice the stated amount of midazolam.
- 2014-06-18FDA-DrugGreenstone LlcClass IVenlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
- 2014-06-11FDA-DrugCarefusion 2200 IncClass IICareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- 2014-06-11FDA-DrugCarefusion 2200 IncClass IICareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- 2014-06-11FDA-DrugHospira Inc.Class IMarcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
- 2014-06-11FDA-DrugGolden State Medical Supply Inc.Class IILOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
- 2014-06-11FDA-DrugPfizer Inc.Class IIGREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
Defective Container: Tamper evident ring failures discovered on some bottles.
- 2014-06-04FDA-DrugWockhardt Usa Inc.Class IIMetoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
- 2014-06-04FDA-DrugTeva Pharmaceuticals USAClass IIParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
Non-sterility: due to a failed sterility test
- 2014-06-04FDA-DrugPrestige Brands HoldingsClass IIIPediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- 2014-06-04FDA-DrugPrestige Brands HoldingsClass IIIPediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- 2014-06-04FDA-DrugDeseo RebajarClass IBurn 7 Capsules, supplied in 30 capsules bottle
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
- 2014-06-04FDA-DrugSandoz, IncClass IICefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.
Presence of Foreign Substance: Presence of stainless steel particles.
- 2014-05-28FDA-DrugIndependent Nutrition Center, Inc.Class IIRed Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402.
Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug.
- 2014-05-28FDA-DrugForest Pharmaceuticals IncClass IIBystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
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