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Medicine Quality Alert: Class II Recall of Izzi Three (Azithromycin 200mg/5ml) Suspension, Batch Number BPL 539 A

The Pharmacy and Poisons Board has mandated the recall of Izzi Three (Azithromycin Oral Suspension B.P. equivalent to Azithromycin anhydrous 200mg), Batch Number BPL 539A, manufactured by Biopharma Limited, due to failure to comply with the specifications of physical appearance.

From: Pharmacy and Poisons Board

Date of Recall Initiation: 20/08/2025

Recall Reference Number: REC/2025/026

Recall Classification: Class II

Recall Level: Retail/Facility level

Manufacturer: Biopharma Ltd

Product name: Izzi Three

Active Pharmaceutical Ingredient: Azithromycin Oral Suspension B.P. equivalent to Azithromycin anhydrous 200mg

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

BPL 539A

11/2023

10/2026

15ml

Brief description of the problem

The product is being recalled due to failure to comply with the specifications of physical appearance, whereby an off-white to light yellow viscous mobile homogenous suspension was observed against the specification of an orange, viscous mobile homogenous suspension. The product had been sampled following a risk-based post-market surveillance.

Action for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Biopharma Limited, Kenya, who will contact healthcare professionals directly to arrange the return.

Action for patients and carers

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 Izzithree oral suspension.

 Further Information

For inquiries about consignments of the impacted batch, please contact Biopharma Limited by email at: info@biopharmaltd.com  Tel: +254 717768794 

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, 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 Izzi Three (Azithromycin Oral Suspension B.P. equivalent to Azithromycin anhydrous 200mg) Batch Number BPL. 539 A.

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