Prescription Drugs

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Failed Dissolution Specifications

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Failed Dissolution Specifications: Out of specification for dissolution.

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Subpotent Drug: Out of specification for assay

CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.

CGMP Deviations: Potential Glass and Silicone particulates in product

Failed Impurities/Degradation Specifications: Out-of-specification test results.

CGMP Deviations: Potential Glass and Silicone particulates in product

CGMP Deviations: Potential Glass and Silicone particulates in product

CGMP Deviations: Potential Glass and Silicone particulates in product

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

CGMP Deviations: Out of specification for residual solvents.

CGMP Deviations: Potential Glass and Silicone particulates in product