Medicines Quality alert: Class II Recall of Biodopa 250mg tablets Batch Number 0321077, 0421142 and 0421112
Biodeal Laboratories Limited is recalling batches 0321077, 0421142, and 0421112 of Biodopa 250mg Tablets due to color change and inconsistent color of the tablets.
From: Pharmacy and Poisons Board
Published: 06/04/2022
Recall Reference Number: REC/2022/04
Recall Classification: Class II
Recall Level: Retail/Facility Level
Company name: Biodeal Laboratories Limited, Kenya
Product name: Biodopa 250mg Tablets
Active Pharmaceutical Ingredient: Methyldopa
Affected batches:
Batch number | Expiry date | Pack Size |
0321077 | 02/2024 | 100’s |
0421142 | 03/2024 | 100’s |
0421112 | 03/2024 | 100’s |
Brief description of the problem
The Pharmacy and Poisons Board has received market complaints of color change/molding of Biodopa tablets, Batch No 0321077 and 0421112. Biodeal Laboratories Ltd initiated a voluntary recall of the above batches, plus 0421142 as a precautionary measure.
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice for patients and caregivers
Biodopa 250mg tablets are used in the management of high blood pressure. You are advised to talk to your healthcare professional if you have the above batches of Biodopa 250mg Tablets. 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 Biodeal Laboratories Limited by email at regulatoryaffairs@biodealkenya.com or by phone +254 720 333 829
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 Recall of Biodopa 250mg tablets Batch Number 0321077, 0421142 and 0421112