Wednesday, October 5

Health withdraws a batch of a drug to prevent cardiac arrhythmias


The Spanish Agency for Medicines and Health Products (Aemps) warns of the withdrawal from the market and the return to the laboratory through the usual channels of a batch of Hydroquinidine Serecor 300 mg. The withdrawal of this drug is due to a result “out of specifications in content detected as a result of stability studies”.

Hydroquinidine Serecor is manufactured by Delpharm Dijon and marketed by Sanofi Aventis. It is a drug based on the substance hydroquinidine hydrochloride, which is used to treat and prevent some serious heart rhythm disorders, as well as to prevent symptoms of electric shock in some patients with an implantable cardioverter-defibrillator (ICD).

The Aemps has informed in a pharmaceutical alert of the affected lot:

  • Lot J0143, which comes in a container of 60 prolonged-release hard capsules with an expiration date of 05/31/2023.

The agency’s statement urges the autonomous communities to monitor its withdrawal, given that the defect has been classified as a class 2 defect. Quality defects in medicines are classified by the Aemps into three classes ( 1, 2 and 3) with class 1 corresponding to a possible higher risk and class 3 corresponding to a lower risk.

Aemps advises users that, if they keep any units from these batches, they contact their usual pharmacist to follow their instructions.

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