D-0365-2022 Class II Terminated
FDA drug recall D-0365-2022 was initiated by Torrent Pharma Inc. on December 2, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated October 23, 2023). Affected quantity: 15,336 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 19, 2022
- Initiation Date
- December 2, 2021
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,336 Bottles
Product Description
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 Pattern
Nationwide USA
Code Information
Batch: 4J11G002 Exp. 08/2024