FDA recall D-395-2014

Product

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

Reason for recall

Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

Distribution

US Nationwide.

Key facts

Status

Terminated

Initiation date

2013-10-11

Report date

2014-01-08

Termination date

2014-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-395-2014