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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

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:

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

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