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.

Failed stability specifications

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

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.