FDA Drug recall D-0078-2023
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma…
- FDA Drug
- Class II
- terminated
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class II recall of FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma… by Ourpharma, citing underfilled units.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0078-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-11-29 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ourpharma |
| Distribution | MO |
Product
FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01
Reason
Underfilled units.
Identifiers
| code_info | Lots: 100122060007 Exp. 12/17/2022; 100122060008 Exp. 12/18/2022; 100122070002 Exp. 01/09/2023. |
|---|
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-0078-2023%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.