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 INC150 Allen RoadSuite 102Basking RidgeNJ 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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