FDA recall D-1317-2020

Product

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

Distribution

USA Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-05-11

Report date

2020-06-10

Termination date

2022-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Basking Ridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2020