Medicine Quality Alert: Class II Medicine Recall of Paradol (Paracetamol 120mg) Oral Solution Batch No. 240831, 240181, 240158, 230215, 240051, 230172 and 240213
The Pharmacy and Poisons Board has mandated Dinlas Pharma (Africa) Ltd to initiate an urgent recall of Paradol (paracetamol) oral solution batch no. 240831, 240181, 240158, 230215, 240051, 230172, and 240213
From: Pharmacy and Poisons Board
Date of Recall Initiation: 20/08/2025
Recall Reference Number: REC/2025/028
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Dinlas Pharma (Africa) Ltd
Product name: Paradol Oral Solution
Active Pharmaceutical Ingredient: Paracetamol 120mg
Affected counties: All
Affected Batches
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
240831 | 08/2024 | 07/2027 | 60ml Bottle |
240181 | 02/2024 | 01/2027 | 60ml Bottle |
240158 | 02/2024 | 01/2027 | 60ml Bottle |
230215 | 09/2023 | 08/2026 | 60ml Bottle |
240051 | 01/2024 | 12/2026 | 60ml Bottle |
230172 | 09/2023 | 08/2026 | 60ml Bottle |
240213 | 02/2024 | 01/2027 | 60ml Bottle |
Brief description of the problem
The product batches are being recalled due to visible presence of particulate matter suspended in the solution. This was observed during investigation of market complaints and analysis of samples collected in risk-based post-market surveillance activity.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Dinlas Pharma (Africa) Ltd to arrange the return.
Action for patients and caregivers
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 batches of Paradol (paracetamol) oral solution.
Further Information
For inquiries about consignments of the impacted batches, please contact Dinlas Pharma (Africa) Ltd at: info@dinlaspharma.com or by Telephone at: +254 782500700/800
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:
- 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 Medicine Recall of Paradol (Paracetamol 120mg) Oral Solution Batch No. 240831, 240181, 240158, 230215, 240051, 230172 and 240213