PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 19, 2022 Initiated: December 2, 2021 #D-0365-2022

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.

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
Torrent Pharma Inc.
Units Affected
15,336 Bottles
Distribution
Nationwide USA
Location
Basking Ridge, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Torrent Pharma Inc.. Units affected: 15,336 Bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on January 19, 2022. Severity: Moderate. Recall number: D-0365-2022.