Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
💊
Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class I - Dangerous
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Bella Vi eXtreme ACCELERATOR 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
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Cubist Pharmaceuticals
Class I - Dangerous
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Fruta BIO 400 mg capsules, supplied in 30 count boxes, 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: Sibutramine and Phenolphthalein .
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
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 AMP'D UP Advanced Weight Loss 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