Prescription Drugs

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Defective Container: Customer complaints of punctures in the bottle.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.

Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.