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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:

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