D-0147-2021 Class III Terminated

Recalled by SCA Pharmaceuticals — Windsor, CT

Recall Details

Product Type
Drugs
Report Date
December 23, 2020
Initiation Date
November 20, 2020
Termination Date
June 24, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,843 syringes

Product Description

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.

Distribution Pattern

Product was distributed to three hospitals in MO & LA.

Code Information

Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021