FDA recall D-380-2014

Hospira Inc. · Class I · drug

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 for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-07-12
Report date: 2013-12-25
Termination date: 2015-02-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-380-2014