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Medicine Quality Alert: Class II Recall of Trimoxol (Cotrimoxazole) Oral Suspension

The Pharmacy and Poisons Board has mandated Dawa Limited, Kenya, to initiate a recall of Trimoxol Oral Suspension.

From: Pharmacy and Poisons Board

Published: 18/09/2023

Recall Reference Number: REC/2023/012

Recall Classification: Class II

Recall Level: Retail/Facility level

Manufacturer: Dawa Limited, Kenya.

Product name: Trimoxol Oral Suspension

Active Pharmaceutical Ingredient: Cotrimoxazole 240mg/5ml

Affected Counties: All

Affected Batches

Batch No

Mfg Date

Exp Date

Pack Size

2201145

01/2022

12/2024

100 ml

2205033

05/2022

04/2025

100 ml

2207184

07/2022

06/2025

100 ml

2210005

10/2022

09/2025

100 ml

2210033

10/2022

09/2025

100 ml

Brief description of the problem

The Pharmacy and Poisons Board (PPB) received multiple market complaints on quality defects of several batches of Trimoxol oral suspension (Cotrimoxazole suspension) manufactured by Dawa LTD, Kenya. The nature of the complaints primarily revolves around the pronounced bitter taste of the suspension, rendering its administration difficult for pediatric patients.

Action for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Dawa Limited, Kenya, who will arrange the return.

Action for patients and carers

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 Trimoxol Suspension.

Further Information

For enquiries about consignments of the impacted batches please contact Dawa Ltd at: info@dawalifesciences.com or bhavisha.vora@dawalifesciences.com or Telephone at +254 733 764 747

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 information please contact the post-marketing surveillance unit at the Pharmacy and Poisons Board by email at pms@ppb.go.ke

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Medicine Quality Alert: Class II Recall of Trimoxol (Cotrimoxazole) Oral Suspension