💊 Drugs • 1,855 recalls
AMMAN PHARMACEUTICAL INDUSTRIES
Lack of Assurance of Sterility
AMMAN PHARMACEUTICAL INDUSTRIES
Lack of Assurance of Sterility
AMMAN PHARMACEUTICAL INDUSTRIES
Lack of Assurance of Sterility
TMC Acquisitions LLC
Lack of Assurance of Sterility
TMC Acquisitions LLC
Lack of Assurance of Sterility
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
CGMP Deviation: impurities exceed allowable limits.
Jarman's Midwest Cleaning Systems
CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
Jarman's Midwest Cleaning Systems
Chemical Contamination: FDA testing found Presence of methanol
Jarman's Midwest Cleaning Systems
Chemical Contamination: FDA testing found Presence of methanol
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
Nanomaterials Discovery
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Denver Solutions, LLC
CGMP DEVIATIONS