Medicine Quality Alert: Class II Medicines Recall Of Tunaclav 228 DT (Amoxicillin/Clavulanic Acid 200/28.5mg) Batch No. 2501726C11, 2501220C11, 2500221C11, and 2400916C11 Manufactured By Medicef Pharma
The Pharmacy and Poisons Board has mandated the recall of Tunaclav 228 DT (Amoxicillin/Clavulanic Acid 200/28.5mg) Batch No. 2501726C11, 2501220C11, 2500221C11, And 2400916C11
From: Pharmacy and Poisons Board
Published: 11th May 2026
Recall Reference Number: REC/2026/011
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Medicef Pharma
LTR: Radiance Pharmaceuticals Ltd
Product name: Tunaclav 228 DT
Active Pharmaceutical Ingredient: Amoxicillin/Clavulanic Acid
Affected counties: All
Affected Batches
S/N | Batch No | Mfg Date | Exp Date | Pack Size |
1. | 2501726C11 | 09/2025 | 08/2027 | 10’s |
2. | 2501220C11 | 06/2025 | 05/2027 | 10’s |
3. | 2500221C11 | 02/2025 | 01/2027 | 10’s |
4. | 2400916C11 | 06/2024 | 05/2026 | 10’s |
Brief description of the problem
Following Post Market Surveillance activities, the Board conducted sampling of Tunaclav 228 DT (Amoxicillin/Clavulanic Acid 200/28.5mg) Batch No. 2501726C11, 2501220C11, 2500221C11 and 2400916C11. The product batches failed to comply with the visual inspection test, where some tablets were observed to be off white in color with yellow spots on the surface of the tablets.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the affected batches of Tunaclav 228 DT (Amoxicillin/Clavulanic Acid 200/28.5mg) Batch No. 2501726C11, 2501220C11, 2500221C11 and 2400916C11 immediately, and contact Radiance Pharmaceuticals Ltd to arrange return.
Action for patients and caregivers
Patients are advised to talk to their healthcare professional if they have the above batches of Tunaclav 228 DT.
Further Information
For any inquiries on consignments please contact Radiance Pharmaceuticals Ltd, by email at radipharm254@gmail.com or via telephone at +254 (0) 722 998 391.
Promptly report any case/s of suspected substandard and falsified products or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board 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 Medicines Recall Of Tunaclav 228 DT (Amoxicillin/Clavulanic Acid 200/28.5mg) Batch No. 2501726C11, 2501220C11, 2500221C11, and 2400916C11 Manufactured By Medicef Pharma