💊 Drugs • 12,141 recalls
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications
Presence of Particulate Matter: identified as glass.
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Zydus Pharmaceuticals (USA)
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Amneal Pharmaceuticals of New York
Failed Dissolution Specifications
Presence of Particulate Matter: identified as glass.
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Dr. Reddy's Laboratories
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Zydus Pharmaceuticals (USA)
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Zyla Life Sciences US
Sub-potent Drug: Lower potency than labeled.
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of specification for dissolution.
Presence of Particulate Matter: identified as glass.
GlaxoSmithKline Consumer Healthcare Holdings
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
GlaxoSmithKline Consumer Healthcare Holdings
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
GlaxoSmithKline Consumer Healthcare Holdings
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Glenmark Pharmaceuticals Inc., USA
Failed Impurities/Degradation Specifications
GlaxoSmithKline Consumer Healthcare Holdings
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.