💊 Drugs • 12,141 recalls
Denver Solutions, LLC
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC
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
Amneal Pharmaceuticals of New York
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
Mallinckrodt Hospital Products
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
Mallinckrodt Hospital Products
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Labeling: Incorrect or Missing Package Insert
CGMP Deviations: potential presence of Burkholderia cepacia complex
Henry Schein Inc. and Glove Club HSI Gloves
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Failed Impurities/Degradation Specification: Out of specification for organic impurities