Drug product
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
D-0647-2017
Product summary
- Event
- Event 76728
- Status
- Terminated
- Classification
- Class III
- Quantity
- 118,224 vials
- Official record key
drug-enforcement:D-0647-2017
Official wording
Reason: Subpotent Drug
Code information: Lot #: 6111141, Exp. 07/17; 6111222, Exp. 08/17; 6112346, Exp. 01/18; 6112725, Exp. 03/18
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Subpotent