Reported Sep 26, 2018 · Terminated

Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT…

Torrent Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Torrent Pharma Inc. · 1803 Whites Rd Ste 1 · Kalamazoo, MI · 49008-2883

Is this the product you have?

  • 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
  • NDC13668-342-30
Lot codes and dates
  • LotBFR5D002 EXP 11-2019
Amount recalled
15,384 30-count bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 4, 2020 · Data as of Sep 19, 8:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.