Product: Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
Reason for recall: Discoloration; Hazy solution found in one vial instead of a clear solution.
Recall initiated: 20191112
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated