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CGMP Deviations
Subpotent Drug: Product does not contain SPF that is declared on the label.
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Non-Sterility
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.