Medicine Quality Alert: Class II Medicine Recall of Cardipril 5 (Enalapril Maleate) Tablets, Batch No. T24A016
The Pharmacy and Poisons Board has mandated Zain Pharma Limited to initiate an urgent recall of Cardipril 5 (Enalapril Maleate) Tablets, Batch No. T24A016
From: Pharmacy and Poisons Board
Date of Recall Initiation: 17th July 2025
Recall Reference Number: REC/2025/023
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Zain Pharma Limited, Kenya
Product name: Cardipril 5 Tablets
Active Pharmaceutical Ingredient: Enalapril Maleate
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
T24A016 | 01/2024 | 12/2026 | 100’s |
Brief description of the problem
The product batch is being recalled due to failure to comply with specifications for hardness test, following an investigation into a market complaint regarding powdering/crumbling of the tablets.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batch immediately. Await contact from Zain Pharma Limited to arrange the 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 Cardipril 5 (Enalapril Maleate) tablets.
Further Information
For inquiries about consignments of the impacted batch, please contact Zain Pharma Limited at: info@zainpharma.co.ke or regulatory@zainpharma.co.ke, or by Telephone at: +254 738 017 004
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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Medicine Quality Alert: Class II Medicine Recall of Cardipril 5 (Enalapril Maleate) Tablets, Batch No. T24A016