💊 Drugs • 12,141 recalls
Sandoz Incorporated
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
VIRTUS PHARMACEUTICALS OPCO II L
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
VIRTUS PHARMACEUTICALS OPCO II L
cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Raritan Pharmaceuticals
CGMP Deviations
Raritan Pharmaceuticals
CGMP Deviations
Raritan Pharmaceuticals
CGMP Deviations
Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.
Love My Tru Body
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Lack of Assurance of Sterility: Potential cracks in glass vials
Ultimate Body Tox
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Colonia Care Pharmacy
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Failed Dissolution Specifications; 6 month time point
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Defective delivery system: detached needles on the syringe in the kit.
Making It a Lifestyle
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
VIRTUS PHARMACEUTICALS OPCO II L
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Inventia Healthcare Private Limited
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
Making It a Lifestyle
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Hospira Inc., A Pfizer Company
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Colonia Care Pharmacy
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.