FDA recall D-1204-2018

Product

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

Nationwide USA

Key facts

Status

Terminated

Initiation date

2018-09-11

Report date

2018-09-26

Termination date

2020-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kalamazoo, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1204-2018