FDA-Drug2018-09-26Class II
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
Torrent Pharma Inc.
Hazard
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Sold states
Nationwide USA
Affected count
15,384 30-count bottles
Manufactured in
1803 Whites Rd Ste 1, N/A, Kalamazoo, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1204-2018Don't want to check this manually?
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