Prescription Drugs

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: product sterility cannot be guaranteed.

Lack of Assurance of Sterility

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Lack of Assurance of Sterility

Lack of Assurance of Sterility