PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 29, 2021 Initiated: August 6, 2021 #D-0807-2021

Product Description

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

Details

Recalling Firm
The Harvard Drug Group
Units Affected
4 Cartons of 100 count each
Distribution
NC
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by The Harvard Drug Group. Units affected: 4 Cartons of 100 count each.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on September 29, 2021. Severity: Moderate. Recall number: D-0807-2021.