Key Takeaway

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 by Torrent Pharmaceuticals Limited was recalled on February 25, 2016. The hazard: Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

FDA Drug Class III Terminated

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

Recalled: February 25, 2016 ~20,952 cartons units affected D-0824-2016

Description

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.

Hazard / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Drugs

Company Information

Torrent Pharmaceuticals Limited

Kadi, N/A, India

View all 1 recalls by Torrent Pharmaceuticals Limited →

Distribution

Nationwide

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