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.
Taro Pharmaceuticals
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.