Fentanyl Citrate Injection — Class II drug recall D-1433-201
Terminated recall by Hospira Inc., reported 2014-07-23, distributed nationwide. Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
| Recall number | D-1433-201 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-06-27 |
| Classified | 2014-07-14 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2015-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 47,400 vials |
| Reason classes | sterility |
| NDC | 00409-9093, 00409-9093-31, 00409-9093-36, 00409-9093-38, 00409-9093-41, 00409-9094, 00409-9094-12, 00409-9094-16, 00409-9094-17, 00409-9094-18, 00409-9094-22, 00409-9094-25, 00409-9094-28, 00409-9094-31, 00409-9094-41, 00409-9094-44, 00409-9094-55, 00409-9094-61 |
| Lot numbers | 39474DK |
| Expiration dates | 2016-03-01 |
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 for recall
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1433-201. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.