D-0147-2021 Class III Terminated
FDA drug recall D-0147-2021 was initiated by SCA Pharmaceuticals on November 20, 2020 and is designated Class III. Reason for recall: Subpotency: Out-of-specification stability test result for low potency was obtained. The recall status is terminated (terminated June 24, 2021). Affected quantity: 4,843 syringes.
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