FDA Drug recall D-0294-2015
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per ca…
- FDA Drug
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per ca… by Hospira, citing lack of Assurance of Sterility; improperly crimped fliptop vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0294-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61
Reason
Lack of Assurance of Sterility; improperly crimped fliptop vials
Identifiers
| ndc | 0409-9093-41 |
|---|---|
| ndc | 0409-9093-36 |
| ndc | 0409-9093-31 |
| ndc | 0409-9093-38 |
| ndc | 0409-9094-12 |
| ndc | 0409-9094-22 |
| ndc | 0409-9094-18 |
| ndc | 0409-9094-25 |
| ndc | 0409-9094-17 |
| ndc | 0409-9094-28 |
| ndc | 0409-9094-16 |
| ndc | 0409-9094-31 |
| ndc | 0409-9094-41 |
| ndc | 0409-9094-61 |
| ndc | 0409-9094-44 |
| ndc | 0409-9094-55 |
| code_info | Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61 |
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-0294-2015%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.