AuroMedics Pharma LLC recalls Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for:
Recalled December 11, 2019 · FDA recall D-0609-2020 · AuroMedics Pharma
Hazard
Discoloration; Hazy solution found in one vial instead of a clear solution. · FDA Class II
Units
59,500 vials
Sold at
Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Description
Discoloration; Hazy solution found in one vial instead of a clear solution.
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
Manufacturer(s)
AuroMedics Pharma LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →