Carbamazepine Tablet, Chewable
FDA Recall NDC 13668-271
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Carbamazepine (NDC 13668-271). A significant event, classified as Class II, was initiated on Dec 02, 2021 by Torrent Pharmaceuticals Limited. The reported reason for this action was: "Failed Dissolution Specifications"
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
Dec 02, 2021
Jan 19, 2022
15,336 Bottles
Recall Profile & Regulatory Data
Event ID
89146
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Torrent Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Oct 23, 2023
Product Description
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
Batch or Lot Expiration Information
Batch# Batch: 4J11G002 Exp. 08/2024
Affected Packages Involved in this Recall
13668-268-30Product
13668-268-01Product
13668-268-10Product
13668-268-31Product
13668-268-05Product
13668-271-01Product
13668-271-10Product
13668-271-49Product
13668-271-05Product
Class II Terminated
Failed Dissolution Specifications
May 11, 2020
Jun 10, 2020
6228 Bottles
Recall Profile & Regulatory Data
Event ID
85644
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Torrent Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide and Puerto Rico
Termination Date
Aug 10, 2022
Product Description
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05
Batch or Lot Expiration Information
Lot# : 4FF4F001, Exp 1/2023
Affected Packages Involved in this Recall
13668-268-30Product
13668-268-01Product
13668-268-10Product
13668-268-31Product
13668-268-05Product
13668-271-01Product
13668-271-10Product
13668-271-49Product
13668-271-05Product
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.
