Prescription and over-the-counter medications
Amneal Pharmaceuticals of New York
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Aurobindo Pharma USA
Failed Impurities/ Degradation Specifications
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
SCA Pharmaceuticals
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Hikma Pharmaceuticals USA
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Aurobindo Pharma USA
Failed Impurities/ Degradation Specifications
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Hikma Pharmaceuticals USA
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Presence of Particulate Matter - found in reserve sample vials at the firm.
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.