FDA recall D-0621-2020

Pacira Pharmaceuticals, Inc. · Class II · drug

Product

EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,

Reason for recall

Sub Potent Drug: Out of Specification (OOS)

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-11-21
Report date
2019-12-11
Termination date
2020-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0621-2020