Drug 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,
D-0621-2020
Product summary
- Event
- Event 84311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 910 20 mL vials
- Official record key
drug-enforcement:D-0621-2020
Official wording
Reason: Sub Potent Drug: Out of Specification (OOS)
Code information: Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification