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Spanish Medicines Agency issues health alert and withdraws some popular high blood pressure pills

The official body has warned of the "detection of an impurity in the active substance irbesartan above its accepted limit"


The Spanish Agency for Medicines and Health Products (Aemps), part of the Ministry of Health, has published a health warning related to two popular drugs used to combat high blood pressure and hypertension.

Specifically, the agency has ordered the withdrawal of several batches of Coaprovel and Karvezide, marketed by the Sanofi laboratory. Both drugs are sold in 28-tablet packs.

Aemps gives the reason for withdrawal as the “detection in the active substance irbesartan of an impurity above its accepted limit”.

The lots affected are the following:

Coaprovel 300 mg / 25 mg (NR: 98086024, CN: 656037)

Lot FT027, expiry date 01/31/2023

Lot FT028, expiry date 01/31/2023

Lot FT029, expiry date 01/31/2023

Karvezide 300 mg / 25 mg (NR: 98085024, CN: 656038)

Lot FT029, expiry date 01/31/2023

The medicines agency has ordered the immediate withdrawal of these drugs from the market and their return to the laboratory, Sanofi Aventis, SA.