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:
- 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 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