FDA Drug recall D-66295-001
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
- FDA Drug
- Class II
- terminated
- Published 2013-10-16
On 2013-10-16 the FDA classified a Class II recall of 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045 by Hospira, citing lack of Assurance of Sterility; potential for vial breakage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66295-001 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-05 |
| Published | 2013-10-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
Product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Reason
Lack of Assurance of Sterility; potential for vial breakage
Identifiers
| ndc | 0409-1159-18 |
|---|---|
| ndc | 0409-1159-01 |
| ndc | 0409-1159-19 |
| ndc | 0409-1159-02 |
| ndc | 0409-1160-18 |
| ndc | 0409-1160-01 |
| ndc | 0409-1162-18 |
| ndc | 0409-1162-01 |
| ndc | 0409-1162-19 |
| ndc | 0409-1162-02 |
| ndc | 0409-1163-18 |
| ndc | 0409-1163-01 |
| ndc | 0409-1165-18 |
| ndc | 0409-1165-01 |
| ndc | 0409-1165-19 |
| ndc | 0409-1165-02 |
| ndc | 0409-9043-11 |
| ndc | 0409-9043-01 |
| ndc | 0409-9046-11 |
| ndc | 0409-9046-01 |
| ndc | 0409-9045-11 |
| ndc | 0409-9045-01 |
| ndc | 0409-9045-16 |
| ndc | 0409-9045-17 |
| ndc | 0409-9042-11 |
| ndc | 0409-9042-01 |
| ndc | 0409-9042-16 |
| ndc | 0409-9042-17 |
| code_info | Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01 |
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-66295-001%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.