Prescription Drugs

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

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

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Failed stability specifications

Subpotent drug

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

cGMP Deviations

Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.