Medicine Quality Alert: Class II Recall of DTS-Z KIT Batch Number 230178/230182, 230179/230182, and 230180/230182
Cosmos Limited has initiated a recall of DTS-Z Kit batches 230178/230182, 230179/230182, and 230180/230182
From: Pharmacy and Poisons Board
Published: 27th March 2024
Recall Reference Number: REC/2023/009
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Cosmos Limited, Kenya
Product name: DTS-Z Kit
Active Pharmaceutical Ingredient: Each 10.30g sachet contains 1.30g Sodium Chloride BP, 0.75mg Potassium Chloride BP, 1.45g Trisodium Citrate BP, 6.75g Anhydrous Glucose BP and each tablet contains 54.89mg Zinc Sulfate Monohydrate USP equivalent to 20mg elemental Zinc.
Affected counties: All
Affected Batches
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
230178/230182 | 08/2023 | 07/2026 | ORS – 4 sachets 500ml + Zinc Sulphate-10 Dispersible Tablets 20mg |
230179/230182 | 08/2023 | 07/2026 | ORS – 4 sachets 500ml + Zinc Sulphate-10 Dispersible Tablets 20mg |
230180/230182 | 08/2023 | 07/2026 | ORS – 4 sachets 500ml + Zinc Sulphate-10 Dispersible Tablets 20mg |
Brief description of the problem
The product is being recalled following several market complaints on quality defects of the product which entails color change and caking.
Action for healthcare professionals
You are advised to immediately quarantine and stop further distribution, sale, issuing, or use of batches 230178/230182, 230179/230182, and 230180/230182 of DTS-Z Kit. Await contact from Cosmos Limited to arrange return.
Action for patients and carers
No 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 dts-Z Kit. 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 inquiries about consignments of the impacted batches, 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 and feedback on the product recall, 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 II Recall of DTS-Z KIT batches 230178/230182, 230179/230182, and 230180/230182