PlainRecalls
FDA Drug Low 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., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.

Reported: April 27, 2016 Initiated: February 25, 2016 #D-0824-2016

Product 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.

Reason for Recall

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

Details

Units Affected
20,952 cartons
Distribution
Nationwide
Location
Kadi, N/A

Frequently Asked Questions

What product 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.. Recalled by Torrent Pharmaceuticals Limited. Units affected: 20,952 cartons.
Why was this product recalled?
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 27, 2016. Severity: Low. Recall number: D-0824-2016.