FDA-Drug2016-04-27Class III

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.

Torrent Pharmaceuticals Limited
Hazard

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

Sold states
Nationwide
Affected count
20,952 cartons
Manufactured in
Ahmedabad Mehsana Highway, N/A, Kadi, N/A, India
Products
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.

Official notice

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

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