Compounded Drugs

Subpotent Drug

Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Lack of Assurance of Sterility

Non-Sterility

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

Subpotent Drug

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

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

Lack of Assurance of Sterility

Non-Sterility

Non-Sterility