Recalls / Class II
Class IID-0365-2022
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.
- Brand name
- Carbamazepine
- Generic name
- Carbamazepine
- Active ingredient
- Carbamazepine
- Route
- Oral
- NDCs
- 13668-268, 13668-271
- FDA application
- ANDA077272
- Affected lot / code info
- Batch: 4J11G002 Exp. 08/2024
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Torrent Pharma Inc.
- Manufacturer
- Torrent Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Allen Rd Ste 102, N/A, Basking Ridge, New Jersey 07920-3856
Distribution
- Quantity
- 15,336 Bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-12-02
- FDA classified
- 2022-01-11
- Posted by FDA
- 2022-01-19
- Terminated
- 2023-10-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0365-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.