Prescription and over-the-counter medications
Jubilant Cadista Pharmaceuticals
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
A-S Medication Solutions
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jubilant Cadista Pharmaceuticals
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Preferred Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Jubilant Cadista Pharmaceuticals
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
A-S Medication Solutions
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Westminster Pharmaceuticals
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.
Westminster Pharmaceuticals
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.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Northwind Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Northwind Pharmaceuticals
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Orexigen Therapeutics
Defective Container: Customer complaints of punctures in the bottle.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Ranier's Compounding Laboratory
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.