FDA Drug recall D-1433-201
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only by Hospira, citing lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1433-201 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-27 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Reason
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
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 #: 39474DK, Expiry: 03/01/2016. |
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-1433-201%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.