FDA Drug recall D-0147-2021
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
- FDA Drug
- Class III
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class III recall of Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205 by Sca Pharmaceuticals, citing subpotency: Out-of-specification stability test result for low potency was obtained.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0147-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-11-20 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | LA, MO |
Product
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
Reason
Subpotency: Out-of-specification stability test result for low potency was obtained.
Identifiers
| code_info | Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0147-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.