Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
West-Ward Pharmaceuticals
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Class I - Dangerous
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.