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
Recall Number: D-0609-2020
Firm: AuroMedics Pharma LLC
Classification: Class II
Status: Terminated
Report Date: 20191211
Initiation Date: 20191112
Termination Date: 20210121
Reason for Recall
Discoloration; Hazy solution found in one vial instead of a clear solution.
Product Description
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