Telmisartan Tablets recalled over foreign material

Recall date

February 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Torrent Pharmaceuticals Limited recalls Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pha…

Recall number

D-0824-2016

FDA classification

Class III

Brand / firm

Torrent Pharmaceuticals Limited

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.