Vimpat Tablet, Film Coated
FDA Recall NDC 0131-2479
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 Vimpat (NDC 0131-2479). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Ucb, Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
882 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35
Batch or Lot Expiration Information
Lot# 912064
Affected Packages Involved in this Recall
0131-2477-35Product
0131-2477-60Product
0131-2477-99Product
0131-2478-35Product
0131-2478-60Product
0131-2478-99Product
0131-2479-35Product
0131-2479-60Product
0131-2479-99Product
0131-2480-35Product
0131-2480-60Product
0131-2480-99Product
0131-1810-67Product
0131-5410-70Product
0131-5410-71Product
0131-5410-72Product
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.
