2,277 recalls · Class II, newest first
Reason Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Reason Failed Dissolution Specifications
Reason Subpotent Drug
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Reason Lack of Assurance of Sterility: leaking bags
Reason The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Lack of Assurance of Sterility: Firm did not perform process validation.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility