Class III · Low risk Terminated
Lamotrigine Tablets
Reason Labeling: Label Error on Declared Strength
Lamotrigine Extended-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
What was recalled
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
- Recalling firm
- Torrent Pharma Inc.
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1204-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lamotrigine recalls
See all
Class II · Moderate risk Terminated
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk Terminated
Lamotrigine Tablets
Reason Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I · High risk Terminated
Lamotrigine Tablets
Reason Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
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