FDA Drug recall D-096-2013
Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01
- FDA Drug
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01 by Hospira, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-096-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-21 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
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.
Identifiers
| ndc | 0409-1463-71 |
|---|---|
| ndc | 0409-1463-01 |
| ndc | 0409-1465-71 |
| ndc | 0409-1465-01 |
| ndc | 0409-1464-61 |
| ndc | 0409-1464-01 |
| ndc | 0409-1467-61 |
| ndc | 0409-1467-01 |
| code_info | Lot #: 11-293-DK, Exp 05/01/13 |
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-096-2013%22
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