FDA Drug recall D-0218-2017
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake…
- FDA Drug
- Class I
- ongoing
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class I recall of Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake… by Hospira A Pfizer, citing presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0218-2017 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2016-08-04 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira A Pfizer |
| Distribution | US |
Product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Reason
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
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 # 59064DK, Exp. 11/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0218-2017%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.