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

Recall Number: D-0147-2021

Firm: SCA Pharmaceuticals

Classification: Class III

Status: Terminated

Report Date: 20201223

Initiation Date: 20201120

Termination Date: 20210624

Reason for Recall

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

Product Description

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