EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 m...
FDA Recall #D-0621-2020 — Class II — November 21, 2019
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,
Reason for Recall
Sub Potent Drug: Out of Specification (OOS)
Recalling Firm
Pacira Pharmaceuticals, Inc. — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
910 20 mL vials
Distribution
Distributed Nationwide in the USA
Code Information
Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated