Health alert: the Medicines Agency withdraws these popular anti-stress drugs

The Spanish Agency for Medicines and Health Products (Aemps), dependent on the Ministry of Health, has ordered the withdrawal of about twenty batches of the high blood pressure drugs Irbesartan and Valsartan, by the presence of an impurity above its limit accepted in its active principles.

Specifically, they are affected Irbesartan Normon 150 mg lots P4E71 AND P4E72; Irbesartan / Hydrochlorothiazide Normon 150 mg / 12.5 mg lots P4DK1, P4DK2 and P4DL1; Irbesartan / Hydrochlorothiazide Normon 300 mg / 25 mg lots P4MD1 and P4DM2; Irbesartan / Hydrochlorothiazide 150mg / 12.5mg Lot 70322; and Lot 63951 of Irbesartan / Hydrochlorothiazide Stada 300 mg / 12.5 mg.

On the other hand, the 11KDAC lot of Amlodipine / Valsartan / Hydrochlorothiazide Stada 10 mg / 160 mg / 26 mg has also been objects of alert; lot 11KDEC of Amlodipine / Valsartan / Hydrochlorothiazide Stada 5 mg / 160 mg / 12.5 mg, lots 11G66A and 11G79A of Valsartan Stada 320 mg; batch 11CN6A of Valsartan / Hydrochlorothiazide Stada 320 mg / 12.5 mg; and lots 11DDHA and 11DD7A of Valsartan / Hydrochlorothiazide Stada 320 mg / 25 mg.

Aemps has also reported the withdrawal of two batches of Coaprovel 300 mg for this same defect. The agency has classified the defect as class 2. The quality defects of the drugs are classified by the Aemps into three classes (1, 2 and 3), class 1 being the one with the highest possible risk and class 3 the one with the lowest risk.

The manufacturers of the products are Laboratorios Normon and Hemofarm AD, while the active ingredient Irbesartan is produced by Zhejiang Huahau Pharmaceutical and that of the active ingredient Valsartan is MSN Life Science. The owners of the commercialization are Laboratorios Normon SA and Laboratorios Stada SL.

After observing this defect, the Aemps has ordered the withdrawal from the market of all the distributed units of the affected lots and their return to the laboratory through the usual channels.


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