D-1317-2020 Class II Terminated

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type
Drugs
Report Date
June 10, 2020
Initiation Date
May 11, 2020
Termination Date
August 10, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6228 Bottles

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

Distribution Pattern

USA Nationwide and Puerto Rico

Code Information

Lot #: 4FF4F001, Exp 1/2023