Prescription Drugs

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

Lack of Assurance of Sterility.

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

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.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

CGMP Deviations

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier