Exparel Injection, Suspension, Liposomal
FDA Recall NDC 65250-133
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Exparel (NDC 65250-133). A significant event, classified as Class II, was initiated on Nov 21, 2019 by Pacira Pharmaceuticals, Inc.. The reported reason for this action was: "Sub Potent Drug: Out of Specification (OOS)"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Sub Potent Drug: Out of Specification (OOS)
Nov 21, 2019
Dec 11, 2019
910 20 mL vials
Recall Profile & Regulatory Data
Event ID
84311
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pacira Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jun 03, 2020
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,
Batch or Lot Expiration Information
Lot# Pacira
Lot# : 19-5002, Patheon manufacturer
Lot# : 098214; Exp. Date: Dec 2019
Affected Packages Involved in this Recall
65250-133-10Product
65250-133-09Product
65250-133-04Product
65250-266-20Product
65250-266-09Product
65250-266-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
