FDAFDA · Food and drugs·Recall number D-1204-2018
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
Published September 26, 2018 · Recall initiated: September 11, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LAMOTRIGINE
- Manufacturer
- Torrent Pharma Inc.
- Distributor
- Nationwide USA
- UPC
- 0313668342307
- Lot
- Lot: BFR5D002 EXP 11-2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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