Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles recall — FDA D-0836-2026
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.