948 recalls · Class II, newest first
Reason Failed Dissolution Specifications; during stability testing
Reason Subpotent: Low anti-factor IIa Potency.
Reason CGMP Deviations
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton…
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity…