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:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Mobile application: mPvERS both Android & iOS
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
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
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Medicine Quality Alert: Class II Medicine Recall of Carvedi-Denk (Carvedilol) 25 mg Batch Number 27374