PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 10, 2020 Initiated: May 11, 2020 #D-1317-2020

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

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
Torrent Pharma Inc.
Units Affected
6228 Bottles
Distribution
USA Nationwide and Puerto Rico
Location
Basking Ridge, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Torrent Pharma Inc.. Units affected: 6228 Bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on June 10, 2020. Severity: Moderate. Recall number: D-1317-2020.