Drug 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
D-0609-2020
Product summary
- Event
- Event 84244
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,500 vials
- Official record key
drug-enforcement:D-0609-2020
Official wording
Reason: Discoloration; Hazy solution found in one vial instead of a clear solution.
Code information: Lot CFD190004, exp. date August 2020
Distribution pattern: Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
Derived failure modes
-
Unknown
Discoloration; Hazy solution found in one vial instead of a clear solution.