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Regulatory Focus™ > News Articles > Following EU Recalls, FDA Announces Voluntary Recall of Drugs Containing Valsartan

Following EU Recalls, FDA Announces Voluntary Recall of Drugs Containing Valsartan

Posted 16 July 2018 | By Zachary Brennan 

Following EU Recalls, FDA Announces Voluntary Recall of Drugs Containing Valsartan

Earlier this month, the European Medicines Agency (EMA) initiated recalls of certain valsartan-containing medicines with active substance supplied by China-based Zhejiang Huahai Pharmaceuticals, pending a review of an impurity. Now the US Food and Drug Administration is announcing a similar voluntary recall.

Both recalls are due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, FDA says, not all products containing valsartan are being recalled.

Recalled Products by FDA
Medicine Company
Valsartan Major Pharmaceuticals
Valsartan Solco Healthcare
Valsartan Teva Pharmaceuticals Industries Ltd.
Valsartan/Hydrochlorothiazide (HCTZ) Solco Healthcare
Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.
“We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

“The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,” FDA said in a statement. “Because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.”

Swissmedic also issued its own separate warning recently, listing drugs other than those listed by FDA.

Elsewhere in Europe, EMA’s Committee for Medicinal Products for Human Use (CHMP) is charged with conducting a review, per the European Commission’s request, of the active substance.

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