Why it was recalled
Sub Potent Drug: Out of Specification (OOS)
Product description
EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,
Lot numbers, UPCs & expiration codes
Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019
Where it was sold
Distributed Nationwide in the USA
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-0621-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 21, 2019
- FDA report date
- Dec 11, 2019
- Quantity
- 910 20 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pacira Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0621-2020, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84311
- Address
- 10450 Science Center Dr
- Code information
- Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019
- Postal code
- 92121-1119
- Report date
- Dec 11, 2019
- Product type
- Drugs
- Recall number
- D-0621-2020
- Classification
- Class II
- Recalling firm
- Pacira Pharmaceuticals, Inc.
- Product quantity
- 910 20 mL vials
- Termination date
- Jun 3, 2020
- Reason for recall
- Sub Potent Drug: Out of Specification (OOS)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 10, 2019