FDA recall D-0824-2016

Product

Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.

Reason for recall

Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-02-25

Report date

2016-04-27

Termination date

2016-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kadi, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0824-2016