Recalls / Class II
Class IID-1317-2020
Product
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
- Brand name
- Carbamazepine
- Generic name
- Carbamazepine
- Active ingredient
- Carbamazepine
- Route
- Oral
- NDCs
- 13668-268, 13668-271
- FDA application
- ANDA077272
- Affected lot / code info
- Lot #: 4FF4F001, Exp 1/2023
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
- 6228 Bottles
- Distribution pattern
- USA Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2020-05-11
- FDA classified
- 2020-06-18
- Posted by FDA
- 2020-06-10
- Terminated
- 2022-08-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1317-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.