FDA recall D-66295-001

Hospira Inc. · Class II · drug

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 for recall

Lack of Assurance of Sterility; potential for vial breakage

Distribution

Nationwide and Guam and Abu Dhabi

Key facts

Status: Terminated
Initiation date: 2013-09-05
Report date: 2013-10-16
Termination date: 2014-10-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66295-001