December 2012 FDA Recall Drug by Pacira Pharmaceuticals, Inc.
D-168-2013 - Subpotent; bupivacaine

This Class II drug recall was voluntarily initiated by Pacira Pharmaceuticals, Inc. on December 17, 2012 for the product Drug. The FDA reported the reason for recall as subpotent; bupivacaine. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-168-2013

Reason for Recall
Subpotent; bupivacaine
Initiated
12-17-2012
Reported
03-06-2013
Quantity
324 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64198
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Pacira Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-03-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009