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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:

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

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