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Medicines Quality alert: Class II Medicines Recall of Pregsmile Tablets Batch Number EKE-235

Dawa Ltd is recalling Pregsmile Tablets Batch number EKE-235 from the Kenyan market.

From: Pharmacy and Poisons Board

Published: 14/01/2022

Recall Reference Number: REC/2022/01

Recall Classification: Class II

Recall Level: Retail/Facility Level

Local Technical Representative: Dawa Ltd

Manufacturer: Corona Remedies Pvt Ltd

Product name: Pregsmile Tablets

Active Pharmaceutical Ingredient: Doxylamine succinate 10mg, Pyridoxine Hcl 10mg, and Folic acid 2mg

Brief description of the problem

Product mix-up. It was found to contain a blister of another product i.e Rosuvastatin

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier.

Advice for patients and caregivers

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 all inquiries on consignments of the impacted batches, please contact Dawa Limited by email at bhavisha.vora@dawalifesciences.com or by phone at +254 713 275 777

Promptly report any case/s of suspected substandard and falsified product or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board through the following channels:

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

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Medicines Quality alert: Class II Medicines Recall of Pregsmile Tablets Batch Number EKE-235