Prescription Drugs

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.

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Microbial contamination of Non-sterile Products; potential B. cepacia contamination

Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil

Microbial contamination of Non-sterile Products; potential B. cepacia contamination