Prescription Drugs

Failed Dissolution Specifications

CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.

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.

Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.

PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

Lack of Assurance of Sterility.