UPDATE on angiotensin II receptor blocker (ARB) recalls: FDA warns Torrent Pharmaceuticals for CGMP violations

UPDATE on angiotensin II receptor blocker (ARB) recalls: FDA warns Torrent Pharmaceuticals for CGMP violations

Today, the U.S. Food and Drug Administration posted a warning letter to Torrent Pharmaceuticals in Ahmedabad, Gujarat, India. Torrent manufactures losartan potassium tablets and has been one subject of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan. 

The warning letter outlines several manufacturing violations at Torrent’s Taluka-Kadi, Indrad, Gujarat facility, including failure to follow written procedures for production and process control and failure to adequately investigate batch discrepancies. Failure to correct these violations may result in further action by the agency. The warning letter is another result of the agency’s ongoing investigation.

FDA reminds patients taking recalled ARBs to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition.

For more information, please visit: FDA Updates and Press Announcements on ARBs.