557 recalls, newest first
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Failed Dissolution Specifications
Reason cGMP Deviations
Reason Out of specification for assay
Reason Subpotent Drug
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Cross Contamination with Other Products
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Reason Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration…
Reason CGMP Deviations
Reason Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Reason CGMP Deviations
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability…
Reason Failed Dissolution Specifications
Reason Failed Impurities/Degradation Specifications
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Reason Lack of Assurance of Sterility: leaking bags