Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

FDA recall notice · announced December 23, 2020 · Sca Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

Reason for recall

Subpotency: Out-of-specification stability test result for low potency was obtained.

Notes

Distribution: Product was distributed to three hospitals in MO & LA.
Lot/code information: Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
Quantity: 4,843 syringes
Status: Terminated
Products in this recall event:
- Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205 (D-0147-2021)

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