FDA on Friday announced Sandoz has voluntarily recalled one lot of its blood pressure drug Hyzaar, after tablets from the lot tested positive for an impurity believed to cause cancer.
The latest action comes after FDA this summer recalled various medications commonly used to treat heart failure and high blood pressure because the drugs tested positive for the organic chemical N- nitrosodimethylamine, which is an impurity the International Agency for Research on Cancer has classified as a probable human carcinogen.
FDA said Sandoz has recalled one lot of Hyzaar because an active pharmaceutical ingredient in the tablets from the lot tested positive for the same impurity.
FDA said Zhejiang Huahai Pharmaceutical Company manufactured the active pharmaceutical ingredient found in the lot of Hyzaar tablets. FDA in September banned Zhejiang Huahai Pharmaceutical Company from importing active pharmaceutical ingredients and finished products into the United States, after the agency conducted an inspection of the manufacturer's facility.
FDA said the voluntarily recall applies to 100mg/25mg tablets of Hyzaar containing "losartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic," which are commonly combined to treat hypertension, with the lot number JB8912. FDA noted Sandoz distributed the affected lot nationally on or after Oct. 8, 2018. FDA estimates the recall affects less than 1% of drug products in the U.S. market containing losartan.
FDA said patients have not yet notified Sandoz of any adverse events related to Hyzaar tablets from the affected lot. FDA advised patients to check their bottles of Hyzaar to determine whether their tablets come from the affected lot. The agency also recommended patients consult with their physicians or pharmacists before they discontinue using affected tablets, because patients might experience worse adverse effects than if they discontinue taking the affected tablets (Christensen, CNN, 11/13; Shoot, Fortune, 11/12; May, USA Today, 11/13).
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