Prescription and over-the-counter medications
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
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
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
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
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
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Novartis Consumer Health
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.