Posted from: Tuesday, December 11, 2018 - 05:03 PM - Present

Sandoz Recalls Losartan Due to NDEA Contamination

November 9, 2018 – Sandoz has voluntarily recalled one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg. The recalled product contains trace amounts of N-nitrosodiethylamine (NDEA), a suspected human carcinogen (cancer-causing agent), from a contaminated active pharmaceutical ingredient (API). The recalled product is one in a series of angiotensin receptor II blocker (ARB) or “sartan” drugs recalled in the United States since July 2018 due to manufacturing impurities.

The recalled losartan contains an API manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd., based in China. The same company supplied valsartan API contaminated with N-nitrosodimethylamine (NDMA) to a number of drug manufacturers who recalled valsartan-containing products earlier in the year.

NDEA occurs naturally in certain foods, drinking water, air pollution, and industrial processes. Patients should continue taking their losartan until they receive a replacement product or speak to their doctor about switching medications, as stopping treatment may pose a significant risk to their health. Patients should speak to their healthcare provider if they experience any adverse effects that may be related to the recalled losartan. Adverse reactions can also be reported to the FDA’s MedWatch program.

Consumers who wish to contact Sandoz with questions about the recall or medication safety can do so at 1-800-525-8747 or usdrugsafety.operations@novartis.com.

According to the FDA, Sandoz supplies less than 1% of the losartan products available on the U.S. market. Further information regarding the recall is available at:

BeneCard PBF’s mail order pharmacy, Benecard Central Fill, has not dispensed any of the recalled product.

 

Last Updated Saturday, May 25, 2019 - 07:08 PM.