723 recalls, newest first
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Reason Subpotent
Reason Subpotent
Reason Subpotent
Reason Subpotent
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Reason Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error…
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Presence of Particulate Matter
Reason CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA…
Reason CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Reason CGMP Deviations
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Lack of Assurance of Sterility: Media fill with bacterial contamination