FDA Drug recall D-1139-2015
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose…
- FDA Drug
- Class III
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class III recall of Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose… by West Ward Pharmaceutical, citing failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1139-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-05-13 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceutical |
| Distribution | US |
Product
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Reason
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Identifiers
| ndc | 0641-6024-01 |
|---|---|
| ndc | 0641-6024-10 |
| ndc | 0641-6027-01 |
| ndc | 0641-6027-25 |
| ndc | 0641-6025-01 |
| ndc | 0641-6025-10 |
| ndc | 0641-6028-01 |
| ndc | 0641-6028-10 |
| ndc | 0641-6028-25 |
| ndc | 0641-6026-01 |
| ndc | 0641-6026-05 |
| ndc | 0641-6029-01 |
| ndc | 0641-6029-25 |
| ndc | 0641-6030-01 |
| ndc | 0641-6247-01 |
| ndc | 0641-6247-25 |
| ndc | 0641-6248-01 |
| ndc | 0641-6248-10 |
| ndc | 0641-6249-01 |
| ndc | 0641-6249-10 |
| code_info | Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 0933…Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1139-2015%22
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