FDA recall D-168-2013

Product

EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA

Reason for recall

Subpotent; bupivacaine

Distribution

Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.

Key facts

Status

Terminated

Initiation date

2012-12-17

Report date

2013-03-06

Termination date

2013-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-168-2013