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
Reported: March 6, 2013 Initiated: December 17, 2012 #D-168-2013
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
Details
- Recalling Firm
- Pacira Pharmaceuticals, Inc.
- Units Affected
- 324 vials
- Distribution
- Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pacira Pharmaceuticals, Inc.. Units affected: 324 vials.
Why was this product recalled? ▼
Subpotent; bupivacaine
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 6, 2013. Severity: Moderate. Recall number: D-168-2013.
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