Bupivacaine HCl Inj — Class II drug recall D-1147-2014
Terminated recall by Hospira Inc., reported 2014-03-12, distributed nationwide. Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
| Recall number | D-1147-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-02-10 |
| Classified | 2014-03-05 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2017-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 115,500 vials |
| Reason classes | foreign material, specification failure |
| 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 | 25-097-DK |
| Expiration dates | 2015-01-01 |
Product
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
Reason for recall
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
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-1147-2014. 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.