FDA Drug recall D-0420-2015
Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, P…
- FDA Drug
- Class III
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class III recall of Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, P… by West Ward Pharmaceutical, citing failed Impurities/Degradation Specifications; 12 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0420-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-02-16 |
| Published | 2015-04-01 |
| 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) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.
Reason
Failed Impurities/Degradation Specifications; 12 month stability testing.
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 #: 113312, Exp 11/2015; 014315 Exp 01/2016 |
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-0420-2015%22
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