Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Prescription Drugs
💊 Drugs • 11,927 recalls
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Lack of Assurance of Sterility
Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Superpotent Drug: Minimally superpotent
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Superpotent Drug
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility