FDA-Drug2018-09-05Class II

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

Torrent Pharma Inc.
Hazard

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Sold states
Nationwide USA
Affected count
14016 bottles
Manufactured in
150 Allen Rd Ste 102, N/A, Basking Ridge, NJ, United States
Products
Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2018

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