Home / Recalls / Torrent Pharma Inc. / D-1204-2018

D-1204-2018 Class II Terminated

Recalled by Torrent Pharma Inc. — Kalamazoo, MI

Recall Details

Product Type
Drugs
Report Date
September 26, 2018
Initiation Date
September 11, 2018
Termination Date
September 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,384 30-count bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Lot: BFR5D002 EXP 11-2019

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