PPB - Services

Complaints, Feedback and Enquiry

Medicine Quality Alert: Class II Medicine Recall of AmoxiClav Denk 1000/125mg powder for oral suspension

Denk Pharma GmbH & Co KG is recalling Amoxiclav Denk (Amoxicillin+Clavulanic Acid) 1000/125mg powder for oral suspension, Batch Number 27608

From: Pharmacy and Poisons Board

Published: 15th May 2024

Recall Reference Number: REC/2024/012

Recall Classification: Class II

Recall Level: Retail/Facility Level

Local Technical Representative (LTR): Laborex Ltd

Manufacturer: Denk Pharma GmbH & Co KG, Germany

Product name: AmoxiClav-Denk

Active Pharmaceutical Ingredient: Amoxicillin & Clavulanic Acid 1000/125mg

Affected Counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

27608

05/2023

05/2026

12’s

Brief description of the problem

Denk Pharma detected an out-of-specification result regarding AmoxiClav-Denk 1000/125, powder for oral suspension, Batch Number 27608. In an ongoing stability study, visual changes in the appearance of a small number of individual sachets were detected.

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 Ltd 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-level recall.

Further Information

For inquiries about consignments of the impacted batch, please contact Surgipharm Limited at: pv.ke@laborex-healthcare.com  or sagak@laborex-healthcare.com or Tel: +254 722 33 58 58, +254 20 69 39 00/137/162

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:

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

Download document

Medicine Quality Alert: Class II Medicine Recall of AmoxiClav Denk 1000/125mg powder for oral suspension