Drug product
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
D-0147-2021
Product summary
- Event
- Event 86802
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,843 syringes
- Official record key
drug-enforcement:D-0147-2021
Official wording
Reason: Subpotency: Out-of-specification stability test result for low potency was obtained.
Code information: Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
Distribution pattern: Product was distributed to three hospitals in MO & LA.
Derived failure modes
-
Potency or specification failure
Subpotency