22. 10. 2021
After the European Directorate for the Quality of Medicines and HealthCare (EDQM) alert due to confirmation of mutagenicity of varied azido impurities in sartan active substances (APIs) with a tetrazole ring, many batches containing valsartan, irbesartan and especially losartan of various manufacturers have been recalled from the markets.
Krka, d. d., Novo mesto, Slovenia has implemented all necessary measures and conducted necessary testing to prove proper control over the mentioned azido impurities. Krka, d. d., Novo mesto, is not affected by the aforementioned recalls.
Krka, d. d., Novo mesto, hereby declares that all batches of its medicinal products, including products with APIs valsartan, candesartan cilexetil, losartan potassium, olmesartan medoxomil, irbesartan hydrochloride and telmisartan are safe, effective and of high quality. They have been continuously available for many years on the markets without restriction.
Krka, d. d., Novo mesto, Slovenia strictly follows the instructions from EMA and fully cooperates with the Slovenian National Agency and other competent authorities around the world. We are well aware of the complexity and seriousness of this matter and, therefore, closely monitor any emerging developments regarding this issue.
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