PPB - Services

Complaints, Feedback and Enquiry

Medicine Quality Alert: Class II Medicine Recall of Carvedi-Denk (Carvedilol) 25 mg  Batch Number 27374

Laborex Kenya Limited has initiated an urgent voluntary recall of Carvedi-Denk (Carvedilol) 25 mg  Batch no; 27374 Manufactured by  Artesan Pharma GmbH & Co. KG

From: Pharmacy and Poisons Board

Published: 17th September 2024

Recall Reference Number: REC/2024/023

Recall Classification: Class II

Recall Level: Retail -level

Local Technical Representative: Laborex Kenya Limited

Manufacturer: Artesan Pharma GmbH & Co. KG

Product name: Carvedi-Denk

Active Pharmaceutical Ingredient: Carvedilol 25mg

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

27374

05/2022

05/2025

Brief description of the problem

Laborex Kenya Limited has initiated an urgent voluntary recall of Carvedi-Denk (Carvedilol) 25 mg  Batch no; 27374 Manufactured by  Artesan Pharma GmbH & Co. KG due to an Out of Specification (OOS) result which was obtained within the on-going stability study at timepoint 24 months (storage conditions 30°C/75% r.h.). The dissolution results did not meet the specification limit Q = 70% (after 45 min). The dissolution was 56.5 % (after 45 min).

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Laborex Kenya Limited to arrange return.

Action for patients and caregivers

No further action is required by patients as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall. You are advised to talk to your healthcare professional if you have the above batch of Carvedi-Denk. The patients to continue taking other batches of the product other than the impacted batch and as prescribed by the healthcare professional.

Further Information

For enquiries about consignments of the impacted batch, please contact Laborex Kenya Limited at: ssavla@laborex-healthcare.com Tel: +254 769579060

Promptly report any case(s) of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further enquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya “the Board” via email at pms@ppb.go.ke and Recall Feedback Form

Download document

Medicine Quality Alert: Class II Medicine Recall of Carvedi-Denk (Carvedilol) 25 mg  Batch Number 27374