💊 Drugs • 12,141 recalls
Palmer Natural Products
Marketed Without an Approved NDA/ANDA: The products are unapproved drugs
Fougera Pharmaceuticals
Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product
Dr. Reddy'S Laboratories
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
West-ward Pharmaceutical
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Subpotent; 22 month stability timepoint
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.
Zydus Pharmaceuticals USA
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
CGMP Deviations: Shipment of product not approved for release.
Hill Dermaceuticals
Subpotent; 12 month stability timepoint
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
West-ward Pharmaceutical
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Physicians Total Care
Subpotent; 15 month stability (by mfr)
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Fresenius Kabi USA LLC (FK USA)
Labeling: Missing label