Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Pantoprazole 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
Legacy Pharmaceutical Packaging
Class I - Dangerous
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Midazolam 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.
Pharmakon Pharmaceuticals
Class I - Dangerous
Superpotent Drug: Product contains twice the stated amount of midazolam.
Class I - Dangerous
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
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Pure Edge Nutrition
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
Vitality Research Labs
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Pure Edge Nutrition
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Pure Edge Nutrition
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL
MyNicNaxs
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
Pure Edge Nutrition
Class I - Dangerous
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I - Dangerous
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
LOSARTAN 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
Golden State Medical Supply
Class I - Dangerous
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
Class I - Dangerous
Defective Container: Tamper evident ring failures discovered on some bottles.
Class I - Dangerous
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.
Class I - Dangerous
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.