Prescription Drugs

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Defective container

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of sterility assurance: leaking bags

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Lack of Assurance of Sterility