Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
Why it was recalled
Subpotent; bupivacaine
Recalling firm
- Firm
- Pacira Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 10450 Science Center Dr, N/A, San Diego, California 92121-1119
Distribution
- Quantity
- 324 vials
- Distribution pattern
- Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
Timeline
- Recall initiated
- 2012-12-17
- FDA classified
- 2013-02-25
- Posted by FDA
- 2013-03-06
- Terminated
- 2013-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-168-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.