EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use...
FDA Recall #D-168-2013 — Class II — December 17, 2012
Product Description
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
Recalling Firm
Pacira Pharmaceuticals, Inc. — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
324 vials
Distribution
Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
Code Information
Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated