Medicine Quality Alert: Class III Recall of Cosatrim DS (Sulfamethoxazole 800mg/Trimethoprim 160mg) Batch Number 210825 and 210828
The Pharmacy and Poisons Board has issued a mandatory recall of Cosatrim DS (Sulfamethoxazole 800mg/Trimethoprim 160mg) batches; 210825 & 210828 by Cosmos Limited.
From: Pharmacy and Poisons Board
Published: 3rd April 2023
Recall Reference Number: REC/2023/003
Recall Classification: Class III
Recall Level: Wholesaler/Distributor level
Manufacturer: Cosmos Limited
Product name: Cosatrim DS
Active Pharmaceutical Ingredient: Sulfamethoxazole 800mg/Trimethoprim 160mg
Affected Counties: All
Affected Batches
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
210825 | 11/2021 | 10/2024 | 100’s |
210828 | 11/2021 | 102024 | 100’s |
Brief description of the problem
The product is being recalled due to several market complaints about a quality defect involving cracking along the tablet score line. Additionally, the Board implemented post-marketing quality surveillance of medical products circulating in the Kenyan market. One of the products sampled and analyzed was Cosatrim® DS tablets (sulfamethoxazole 800 mg/trimethoprim 160 mg), from batches 210825 and 210828. The product failed to meet the specifications, as the tablets were found to be broken along the score lines and into two or more pieces.
Action for healthcare professionals
You are advised to immediately quarantine and stop supplying batches 210825 and 210828 of Cosatrim DS 960 from Cosmos Limited, Kenya, and contact Cosmos Ltd to arrange for the return of the products.
Action for patients and carers
No action is required for patients as this is a Wholesaler/Distributor level of recall. Patients currently prescribed Cosatrim DS (Sulfamethoxazole 800mg/Trimethoprim 160mg) batches; 210825 and 210828 should contact their healthcare professional. The patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.
Further Information
For any stock enquiries please contact Cosmos Limited, Kenya at: info@cosmos-pharm.com or via telephone: + 254 (0) 709 864 000,+ 254 (0) 722 333 834,+ 254 (0) 733 666 834
You are advised to 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: pms@ppb.go.ke
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Medicine quality alert: Class 3 Recall of Cosatrim DS (Sulfamethoxazole 800mg/Trimethoprim 160mg) Batch Number 210825 and 210828