0 — Class II drug recall D-395-2014
Terminated recall by Hospira Inc., reported 2014-01-08, distributed nationwide. Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
| Recall number | D-395-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-10-11 |
| Classified | 2014-01-02 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-11-10 |
| Distributed | Nationwide (US) |
| Quantity | 65,109 vials |
| Reason classes | sterility |
| NDC | 00409-1159, 00409-1159-01, 00409-1159-02, 00409-1159-18, 00409-1159-19, 00409-1160, 00409-1160-01, 00409-1160-18, 00409-1162, 00409-1162-01, 00409-1162-02, 00409-1162-18, 00409-1162-19, 00409-1163, 00409-1163-01, 00409-1163-18, 00409-1165, 00409-1165-01, 00409-1165-02, 00409-1165-18, 00409-1165-19, 00409-9042, 00409-9042-01, 00409-9042-11, 00409-9042-16 and 12 more |
| Lot numbers | 32-484-EV, 32-485-EV |
| Expiration dates | 2015-02 |
Product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Reason for recall
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
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-395-2014. 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.