Posted from: Monday, October 08, 2018 - 12:40 PM - Present

New Impurity Found in Recalled Valsartan Product

September 13, 2018 – The U.S. FDA has identified an additional impurity in valsartan-containing drugs originally recalled due to NDMA (N-Nitrosodimethylamine) contamination. Torrent Pharmaceuticals, the manufacturer, recalled the products in question on August 23, 2018. The latest tests have shown that the valsartan active pharmaceutical ingredient (API) contains not only traces of NDMA, but also of N-Nitrosodiethylamine (NDEA).

Like NDMA, NDEA is considered a possible human carcinogen, or cancer-causing agent. The FDA believes that the substance contaminated the API during the manufacturing process, as was the case with NDMA. NDEA was found in Torrent’s already recalled valsartan 160mg (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets, which were made using valsartan API supplied by Zhejiang Huahai Pharmaceuticals.

At present, the FDA’s instructions regarding valsartan recalls have not changed, and no new recalls have been issued due to the NDEA found in valsartan API. The FDA advises patients to continue taking their medication until they have received a supply of valsartan not affected by recalls, or have been switched to a different angiotensin II receptor blocker (ARB) by their prescriber.

The FDA is continuing its investigation into impurities in valsartan APIs. Additional information on the presence of NDEA in some valsartan-containing products is available at:

 

 

Last Updated Friday, October 19, 2018 - 04:43 PM.