Medicine Quality Alert: Class II Medicine Recall of Topfoliferum (Ferrous Sulphate+Folic Acid) Tablets Batch Number 240726
Topstone Pharma Ltd has initiated a voluntary recall of Topfoliferum Tablets (Ferrous sulphate+Folic acid) BN 240726
From: Pharmacy and Poisons Board
Date of Recall Initiation: 19th March 2025
Recall Reference Number: REC/2025/009
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Liaoning Huarui Union Pharmaceutical Co., Ltd, China
Local Technical Representative: Topstone Pharma Ltd
Product name: Topfoliferum
Active Pharmaceutical Ingredient: Ferrous Sulphate 200mg+Folic Acid 0.4mg
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
240726 | 07/2024 | 07/2027 | 100’s |
Brief description of the problem
Topstone Pharma Ltd has initiated a voluntary recall of Topfoliferum Tablets (Ferrous sulphate+Folic acid) BN 240726 due to market complaints of color change with some tablets becoming darker with black particles.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batch immediately. Await contact from Topstone Pharma 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 batch of Topfoliferum Tablets. The patients should continue taking other batches of the product other than the impacted batch and as prescribed by the healthcare professional.
Further Information
For inquiries about consignments of the impacted batch, please contact Sphinx Pharmaceuticals Ltd at: regulatory@topstonepharma.co.ke or by Telephone at: +254 768 217 670
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:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
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 Topfoliferum (Ferrous Sulphate+Folic Acid) Tablets Batch Number 240726