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

Recall date

September 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1204-2018

FDA classification

Class II

Brand / firm

Torrent Pharma Inc.

Sold / distributed

Nationwide USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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