Nalbuphine HCl Injection — Class II drug recall D-096-2013
Terminated recall by Hospira, Inc., reported 2012-12-26, distributed nationwide. Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper
| Recall number | D-096-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira, Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-11-21 |
| Classified | 2012-12-20 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2014-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 145,400 vials |
| Reason classes | sterility |
| NDC | 00409-1463, 00409-1463-01, 00409-1463-71, 00409-1464, 00409-1464-01, 00409-1464-61, 00409-1465, 00409-1465-01, 00409-1465-71, 00409-1467, 00409-1467-01, 00409-1467-61 |
| Lot numbers | 11-293-DK |
| Expiration dates | 2013-05-01 |
Product
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
Reason for recall
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
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-096-2013. 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.