The Spanish Agency for Medicines and Health Products (Aemps) has withdrawn a batch of Hydroquinidine Serecor 300 mg, used in the prevention of cardiac disorders, from the marketplace.
The state body has said thar the decision is due to an "out-of-specification result in content detected as a result of stability studies".
Hydroquinidine Serecor, manufactured by Delpharm Dijon and marketed by Sanofi Aventis, contains the active substance hydroquinidine hydrochloride and is used to treat and prevent some serious heart rhythm disorders, as well as to prevent symptoms of electric shock in some patients with implantable cardioverter defibrillators.
The affected batch of the 60 slow-release hard capsules is numbered J0143, with an expiry date of 31/05/2023. Aemps, which reports to the ministry of Health, has asked the autonomous communities to monitor the withdrawal of the product.