Prescription and over-the-counter medications
SUN PHARMACEUTICAL INDUSTRIES
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Perrigo Company PLC
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Aroma Release Technologies
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
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