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

FDA recall notice · announced December 11, 2019 · Auromedics Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Lot/code information: Lot CFD190004, exp. date August 2020
Quantity: 59,500 vials
Status: Terminated
Products in this recall event:
- 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 (D-0609-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.