FDA recall D-0365-2022

Torrent Pharma Inc. · Class II · drug

Product

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

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2021-12-02
Report date: 2022-01-19
Termination date: 2023-10-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Basking Ridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0365-2022