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Medicine Quality Alert: Class II Medicines Recall of CEFUKEN DS 125 (Cefuroxime Axetil) Suspension Batch Number 44B5411

The Pharmacy and Poisons Board has mandated the recall of Ciprolab 500 (Ciprofloxacin) Tablets, manufactured by Relax Biotech Pvt. Ltd., India

From: Pharmacy and Poisons Board

Published: 23rd December 2025

Recall Reference Number: REC/2025/039

Recall Classification: Class II

Recall Level: Retail/Facility Level

Manufacturer: Relax Biotech Pvt. Ltd., India

Local Technical Representative: Pharmaken Ltd

Product name: Cefuken DS

Active Pharmaceutical Ingredient: Cefuroxime Axetil for Oral Suspension 125mg/5ml

Affected counties: All

Affected Batches

S/N

Batch No

Mfg Date

Exp Date

Pack Size

1.     

44B5411

10/2024

09/2026

50ml

Brief description of the problem

Following Risk-Based Post-Market Surveillance Activities, the Pharmacy and Poisons Board sampled and tested Cefuken DS Batch No 44B5411 and found that it did not meet the required specifications for the Assay test. PPB has therefore mandated the recall of this product batch from the market.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing, or use of Cefuken DS Batch No 44B5411 immediately, and contact Pharmaken Ltd to arrange return.

Action for patients and caregivers

Patients are advised to talk to their healthcare professional if they have the above batch of Cefuken DS Suspension.

Further Information

For any inquiries on consignments please Pharmaken ltd, by email at msa@pharmaken.net or via telephone at +254717685075 or +254 839 107

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

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Medicine Quality Alert: Class II Medicines Recall of CEFUKEN DS 125 (Cefuroxime Axetil) Suspension Batch Number 44B5411
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