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Information about Valsartan

Over the last few weeks, many pharmaceutical companies around the world have taken a precautionary measure and recalled a variety of preparations containing valsartan. Valsartan is a medicine used to treat high blood pressure and mild to moderate heart failure. This precautionary recall is due to the production-related contamination of valsartan, the medicine's active ingredient. This has also led STADA and its national and international subsidiaries to immediately recall the affected batches from the market.

According to the European Medicine Agency (EMA), no acute danger exists for patients. Since it is now known which medicines containing valsartan are not affected by the recall, the national authorities recommends switching to the unaffected medicines. Authorities state that patients should not stop taking the medicine of their own, but rather contact their doctor or pharmacist immediately.

Contamination of the active ingredient is likely the result of changes to the production process made by the manufacturer of the active ingredient in 2012. However, STADA Arzneimittel AG and its subsidiaries only began using this manufacturer's active ingredient starting in May 2016.

Naturally, after becoming aware of valsartan’s potential contamination, STADA took the time to review other products of this active ingredient class, such as irbesartan, as a precaution. Our present knowledge indicates that other medicines containing sartan are excluded from contamination. For this reason, it is not necessary to recall these products at the present time.

Further information is available at www.ema.europa.eu/ema/

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