Recalls / Class II
Class IID-0807-2021
Product
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61
- Brand name
- Carbamazepine
- Generic name
- Carbamazepine
- Active ingredient
- Carbamazepine
- Route
- Oral
- NDCs
- 0904-3854, 0904-6172
- FDA application
- ANDA075712
- Affected lot / code info
- Lot R01562; Exp. 10/2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17187 N Laurel Park Dr Ste 300, Livonia, Michigan 48152-2600
Distribution
- Quantity
- 4 Cartons of 100 count each
- Distribution pattern
- NC
Timeline
- Recall initiated
- 2021-08-06
- FDA classified
- 2021-09-17
- Posted by FDA
- 2021-09-29
- Terminated
- 2022-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0807-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.