Drug 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
D-168-2013
Product summary
- Event
- Event 64198
- Status
- Terminated
- Classification
- Class II
- Quantity
- 324 vials
- Official record key
drug-enforcement:D-168-2013
Official wording
Reason: Subpotent; bupivacaine
Code information: Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
Distribution pattern: Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
Derived failure modes
-
Potency or specification failure
Subpotent