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:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email: pv@ppb.go.ke and pms@ppb.go.ke
- Telephone number. 0795743049
- Mobile application: mPvERS both Android and iOS
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