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:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
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