Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
Recalls
- Sep 11, 2018 · Class II · Torrent Pharma Inc.
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Lots: Lot: BFR5D002 EXP 11-2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lamotrigine: every company that makes it
- Form
- tablet, extended release
- Strength
- 200 mg
- Approval
- ANDA ANDA203370
- On the market since
- Dec 23, 2013
- Package NDCs
13668-342-0113668-342-30- Official label
- DailyMed (National Library of Medicine), updated Mar 4, 2026
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