Recalls / Class II
Class IID-1204-2018
Product
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
- Brand name
- Lamotrigine
- Generic name
- Lamotrigine
- Active ingredient
- Lamotrigine
- Route
- Oral
- NDCs
- 13668-339, 13668-340, 13668-341, 13668-342
- FDA application
- ANDA203370
- Affected lot / code info
- Lot: BFR5D002 EXP 11-2019
Why it was recalled
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Recalling firm
- Firm
- Torrent Pharma Inc.
- Manufacturer
- Torrent Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1803 Whites Rd Ste 1, N/A, Kalamazoo, Michigan 49008-2883
Distribution
- Quantity
- 15,384 30-count bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2018-09-11
- FDA classified
- 2018-09-20
- Posted by FDA
- 2018-09-26
- Terminated
- 2020-09-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1204-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.