FDA recall D-1147-2014

Hospira Inc. · Class II · drug

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.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-02-10
Report date: 2014-03-12
Termination date: 2017-02-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1147-2014