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Medicine Quality Alert: Class II Recall of Beeclav (Amoxicillin & Clavulanic acid 457mg, 70ml) Batch Number SEBPD-0088

The Pharmacy and Poisons Board has issued a mandatory recall of Beeclav (Amoxicillin & Clavulanic acid 457mg, 70ml) batch number SEBPD-0088 due to a color change to brown after reconstitution.

From: Pharmacy and Poisons Board

Published: 17/10/2023

Recall Reference Number: REC/2023/015

Recall Classification: Class II

Recall Level: Retail/Facility level

Local Technical Representative: Krishna Chemist Limited, Kenya.

Manufacturer: Saitech Medicare PVT Ltd, India

Product name: Beeclav Suspension

Active Pharmaceutical Ingredient: Amoxicillin & Clavulanic acid 457mg, 70ml

Affected Counties: All

Impacted batch:

Batch Number

Date of Manufacture

Date of expiry

Pack Size

SEBPD-0088

08/2022

07/2024

70 ml

Brief description of the problem

The product is being recalled following market complaints on quality defects on color change for batch SEBPD-0088. On further investigations, it was noted that there was a color change of the reconstituted suspension, indicating discrepancies from the product’s intended physical characteristics.

Action for healthcare professionals

You are advised to stop supplying the above batch and immediately quarantine all remaining stocks. The company Krishna Chemist Limited, Kenya, will contact healthcare professionals directly to arrange for the return of the products.

Action for patients and carers

Patients currently prescribed Beeclav (Amoxicillin & Clavulanic acid 457mg 70ml) batch; SEBPD-0088 should contact their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.

Further Information

For inquiries about consignments of the impacted batches, please contact

Krishna Chemist Limited at: regulatory@krishnachemists.com or Tel: +254 722 366 988, +254 714 714 178, +254 715 946 380

You are advised to promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine Quality Alert: Class II Recall of Beeclav (Amoxicillin & Clavulanic acid 457mg, 70ml) Batch Number SEBPD-0088