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Medicine Quality Alert: Class II Medicine Recall of MZ-CAL Plus Suspension Batch number GE-13170

Galaxy Pharmaceutical Ltd has initiated an urgent recall of MZ-CAL Plus Suspension, Batch No GE-13170.

From: Pharmacy and Poisons Board

Published: 25th March 2024

Recall Reference Number: REC/2024/008

Recall Classification: Class II

Recall Level: Retail/Facility level

Manufacturer: Enicar Pharmaceuticals Pvt Ltd, India

Local Technical Representative: Galaxy Pharmaceutical Ltd

Product name: MZ-CAL Plus  Suspension

Active Pharmaceutical Ingredient: As milk calcium Elemental Calcium 150mg, Elemental Phosphorus 75mg, Elemental Magnesium 37.5mg, Elemental Zinc 2mg, Vitamin D3 (Cholecalciferol) B.P 200 IU, Appropriate overages of vitamins added.

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

GE-13170

07/2023

06/2025

200 ml

Brief description of the problem

Galaxy Pharmaceutical Ltd is recalling batch GE-13170, following market complaints of black spots in the suspension.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Galaxy Pharmaceutical Ltd to arrange the return.

Action for patients and caregivers

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 MZ-CAL Plus Suspension. 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 inquiries about consignments of the impacted batches, please contact Galaxy Pharmaceutical Ltd at: info@galaxypharma.co.ke or pvigilance@galaxypharma.co.ke or by Telephone at: +254 3748551/2/3/4

You are advised to promptly report any case(s) of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke

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Medicine Quality Alert: Class II Medicine Recall of MZ-CAL Plus  Suspension Batch number GE-13170