Medicine Quality Alert: Class II Recall of Ibuflam Plus Suspension Batch Number 0623005
Biodeal Laboratories Ltd has initiated a voluntary recall of Ibuflam Plus Suspension (Paracetamol and Ibuprofen) BN 0623005
From: Pharmacy and Poisons Board
Date of Recall Initiation: 3rd June 2025
Recall Reference Number: REC/2025/019
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Biodeal Laboratories Ltd, Kenya
Product name: Ibuflam Plus
Active Pharmaceutical Ingredients: Ibuprofen 100mg + Paracetamol 125mg/5ml
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
0623005 | 06/2023 | 05/2026 | 60ml |
Brief description of the problem
Biodeal Laboratories Ltd is conducting a voluntary recall due to failure to comply with the specifications for pH and Assay tests. The sample was collected during a Good Manufacturing Practice (GMP) Inspection by the Pharmacy and Poisons Board, and analysis was undertaken.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Biodeal Laboratories Ltd, Kenya, who will contact healthcare professionals directly to arrange the return.
Action for patients and carers
Patients should continue taking other batches of the product, excluding the impacted batch, and as prescribed by their healthcare professional.
Further Information
For inquiries about consignments of the impacted batches, please get in touch with Biodeal Laboratories Ltd, Kenya, at: regulatoryaffairs@biodealkenya.com, chriskibathi@biodealkenya.com, freshia@biodealkenya.com, or via telephone at +254 722 214178
Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or 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
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 Recall of Ibuflam Plus Suspension Batch Number 0623005