Medicine Quality Alert: Class II Recall of Cardoz 12.5 (Carvedilol 12.5 mg) Tablets, Batch no. GBC013001
Sai Pharmaceuticals Kenya Limited has initiated a voluntary recall of Cardoz 12.5 (Carvedilol 12.5 mg) Tablets, Batch no. GBC013001 Manufactured by Ipca Laboratories Limited, India.
From: Pharmacy and Poisons Board
Date of Recall Initiation: 14/11/2025
Recall Reference Number: REC/2025/035
Recall Classification: Class II
Recall Level: Retail/Facility level
Local Technical Representative: Sai Pharmaceuticals Kenya Limited
Manufacturer: Ipca Laboratories Limited
Product name: Cardoz 12.5
Active Pharmaceutical Ingredient: Carvedilol 12.5 mg
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
GBC013001 | 01/2023 | 12/2025 | 2 x 14 tablets |
Brief description of the problem
The product is being recalled due to observed assay results of 94.7% against the specification limit of 95.0% to 105.0% at 24-month time point at storage condition 30°C/75%RH.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Sai Pharmaceuticals Kenya Limited to arrange the return.
Action for patients and carers
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 Cardoz 12.5 (Carvedilol 12.5 mg) Tablets.
Further Information
For inquiries about consignments of the impacted batch, please contact Sai Pharmaceuticals Kenya Limite by email at: head-regulatory@saipharm.com Tel: 0721243322
You are advised to 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#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke
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