PPB - Services

Complaints, Feedback and Enquiry

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:

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

Download Document

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