RecallRadar

FDA Drug recall D-380-2014

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02

On 2013-12-25 the FDA classified a Class I recall of 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02 by Hospira, citing presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-380-2014
ClassificationClass I
Statusterminated
Initiated2013-07-12
Published2013-12-25
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02

Reason

Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.

Identifiers

ndc0409-1159-18
ndc0409-1159-01
ndc0409-1159-19
ndc0409-1159-02
ndc0409-1160-18
ndc0409-1160-01
ndc0409-1162-18
ndc0409-1162-01
ndc0409-1162-19
ndc0409-1162-02
ndc0409-1163-18
ndc0409-1163-01
ndc0409-1165-18
ndc0409-1165-01
ndc0409-1165-19
ndc0409-1165-02
ndc0409-9043-11
ndc0409-9043-01
ndc0409-9046-11
ndc0409-9046-01
ndc0409-9045-11
ndc0409-9045-01
ndc0409-9045-16
ndc0409-9045-17
ndc0409-9042-11
ndc0409-9042-01
ndc0409-9042-16
ndc0409-9042-17
code_infoLot # 18-136-DK; Exp. 6/14

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-380-2014%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.