FDA recall D-1136-2018

Torrent Pharma Inc. · Class II · drug

Product

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status
Ongoing
Initiation date
2018-08-17
Report date
2018-09-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Basking Ridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1136-2018