Lamotrigine Tablet, Extended Release
FDA Recall NDC 13668-340
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 Lamotrigine (NDC 13668-340). A significant event, classified as Class II, was initiated on Sep 11, 2018 by Torrent Pharmaceuticals Limited. The reported reason for this action was: "Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing."
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
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Sep 11, 2018
Sep 26, 2018
15,384 30-count bottles
Recall Profile & Regulatory Data
Event ID
80985
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Torrent Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 04, 2020
Product Description
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Batch or Lot Expiration Information
Lot# Lot: BFR5D002 EXP 11-2019
Affected Packages Involved in this Recall
13668-339-30Product
13668-339-01Product
13668-339-05Product
13668-340-30Product
13668-340-01Product
13668-340-05Product
13668-341-30Product
13668-341-01Product
13668-341-05Product
13668-342-30Product
13668-342-01Product
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.
