FDA recall D-0807-2021

The Harvard Drug Group · Class II · drug

Product

Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61

Reason for recall

Failed Dissolution Specifications

Distribution

Key facts

Status: Terminated
Initiation date: 2021-08-06
Report date: 2021-09-29
Termination date: 2022-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0807-2021