Prescription and over-the-counter medications
Longbow First Aid Products Manufactory
CGMP Deviations
Guardian Pharmacy Services
Lack of sterility assurance.
Longbow First Aid Products Manufactory
CGMP Deviations
Guardian Pharmacy Services
Lack of sterility assurance.
Guardian Pharmacy Services
Lack of sterility assurance.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
West-Ward Columbus
Failed Dissolution Specifications:
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
West-Ward Columbus
Failed Dissolution Specifications:
Bryant Ranch Prepack
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Bryant Ranch Prepack
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Hetero Labs, Ltd. - Unit III
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Carcinogen impurity detected in API used to manufacture drug product.
Failed Dissolution Specifications
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Failed Tablet/Capsule Specifications: Tablet breakage
Failed Stability Specifications: lot out of specification for elevated water vapor.