NDC 42291-369
Lamotrigine 200 mg tablet
On the label: AvKARE, Inc.. It's repackaged: AvKARE, Inc. rebottles it from Jubilant Cadista Pharmaceuticals Inc.'s NDC 59746-248.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| InvaTech Pharma Solutions LLC | East Brunswick, NJ, United States | Makes it | Problems found, fixed voluntarilyMay 13, 2026 · 4 inspections |
| i3 Pharmaceuticals, LLC | Warminster, PA, United States | Makes it | Problems found, fixed voluntarilyMay 22, 2026 · 4 inspections |
Recalls
- Jul 20, 2022 · Class III · AVKARE Inc.
Labeling: Label Error on Declared Strength
Lots: Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022 - May 28, 2020 · Class III · AVKARE Inc.
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Lots: Lot #: a) 25634, b) 25633; Exp. 09/30/2021
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, oral
- Strength
- 200 mg
- Approval
- ANDA ANDA079132
- On the market since
- Apr 10, 2013
- Package NDCs
42291-369-5042291-369-60- Official label
- DailyMed (National Library of Medicine), updated May 13, 2026
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