Why it was recalled
Subpotent; bupivacaine
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
Lot numbers, UPCs & expiration codes
Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
Where it was sold
Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-168-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2012
- FDA report date
- Mar 6, 2013
- Quantity
- 324 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pacira Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-168-2013, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64198
- Address
- 10450 Science Center Dr
- Code information
- Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
- Postal code
- 92121-1119
- Report date
- Mar 6, 2013
- Product type
- Drugs
- Recall number
- D-168-2013
- Classification
- Class II
- Recalling firm
- Pacira Pharmaceuticals, Inc.
- Product quantity
- 324 vials
- Termination date
- May 3, 2013
- Reason for recall
- Subpotent; bupivacaine
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
- Recall initiation date
- Dec 17, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Feb 25, 2013