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.
FDA recall notice · announced January 19, 2022 · Torrent Pharma
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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
Notes
Distribution: Nationwide USA
Lot/code information: Batch: 4J11G002 Exp. 08/2024
Quantity: 15,336 Bottles
Status: Terminated
Products in this recall event:
- 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 0792 (D-0365-2022)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.