Recalls / Class II
Class IID-0621-2020
Product
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,
- Brand name
- Exparel
- Generic name
- Bupivacaine
- Active ingredient
- Bupivacaine
- Route
- Infiltration
- NDCs
- 65250-133, 65250-266
- FDA application
- NDA022496
- Affected lot / code info
- Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019
Why it was recalled
Sub Potent Drug: Out of Specification (OOS)
Recalling firm
- Firm
- Pacira Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10450 Science Center Dr, San Diego, California 92121-1119
Distribution
- Quantity
- 910 20 mL vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2019-11-21
- FDA classified
- 2019-12-10
- Posted by FDA
- 2019-12-11
- Terminated
- 2020-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0621-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.