The National Medicines Regulatory Authority of Cote d’Ivoire, l’AIRP, has issued a rapid alert on CARVEDI-DENK (carvedilol) 25 mg tablets due to quality concerns.
In the notification, the authority references an alert issued by the World Health Organization (Ref: WHO Medical Product Alert No. 3/2024: Rapid Alert Notification Quality Defect_II_H_Carvedi-Denk) that indicated the stability analysis results of the product were out of specification and therefore not of good quality.
Usage
Carvedi-Denk 25 mg, whose active pharmaceutical ingredient is carvedilol, is a product by the German pharmaceutical company Denk Pharma GmbH & CO.KG. The medicine is widely used in the management of heart failure, high blood pressure, and angina.
Product details and reason for alert
The affected products hold batch number 27374, a manufacturing date of May 2022, and an expiration date of May 2025.
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According to the notification issued by the Ivorian authority, stability tests on the Carvedi-Denk had been ongoing for the last 24 months, and the results showed that the dissolution rates were not within the specification limits.
Advice from l’AIRP
The Ivorian regulatory authority has urged wholesale distributors who deal with the product to trace and recall the affected batch from the supply chain.
It has also advised healthcare professionals to be vigilant and report any adverse effects experienced after use of the product.
Source: L’AIRP
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