FDA Drug recall D-0954-2022
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B o…
- FDA Drug
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B o… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0954-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-18 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sterile Compounding Center |
| Distribution | US |
Product
Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL), 150 mL IV Bag, 10 x 1 IV Bag, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: FN1088A, Exp. 6/21/2022; FN1089A, Exp. 6/26/2022 |
|---|
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-0954-2022%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.