FDA recall D-1138-2018

Product

Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30

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-1138-2018