Status
Terminated
Drug Enforcement D-168-2013
Subpotent; bupivacaine
Classification
Class II
Report Date
March 6, 2013
Termination Date
May 3, 2013
Product Information
- 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
- Product quantity
- 324 vials
- Reason for recall
- Subpotent; bupivacaine
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
Location & Firm
- Recalling firm
- Pacira Pharmaceuticals, Inc.
- Address
-
10450 Science Center Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-168-2013
- Event ID
- 64198
- Recall initiation date
- December 17, 2012
- Center classification date
- February 25, 2013
- Code info
- Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
- More code info
- —