Medicine Quality Alert: Class I Medicine Recall of Flurasted 500 (5-Fluorouracil) Injection Batch no. HHP24017
The Pharmacy and Poisons Board has mandated Medserv Africa Ltd to initiate an urgent recall of Flurasted 500 (5-fluorouracil) injection, Batch No. HHP24017 Manufactured by Halsted Pharma Private Limited
From: Pharmacy and Poisons Board
Date of Recall Initiation: 6th January 2025
Recall Reference Number: REC/2025/002
Recall Classification: Class I
Recall Level: Consumer-level
Manufacturer: Halsted Pharma Private Limited
Product name: Flurasted 500
Active Pharmaceutical Ingredient: 5-fluorouracil
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
HHP24017 | 07/2024 | 06/2026 | 5 ampoules |
Brief description of the problem
The product is being recalled due to detection of particles in the injectable medicinal product.
Action for healthcare professionals
Quarantine all the remaining stock and stop further distribution, sale, issuing or use of the batch IMMEDIATELY. Await contact from Medserv Africa Ltd to arrange the return.
Action for patients and members of the public
No further action is required by patients as this product is usually administered by healthcare professionals in a hospital setting, and the recall is a Retail/Hospital Pharmacy and Wholesaler/Distributor level recall.
Further Information
For inquiries about consignments of the impacted batch, please contact Medserv Africa Ltd at: medservsupplies@gmail.com or Phone: +254 (0) 724040388.
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#
- Mobile application: mPvERS both Android & iOS
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
For any further enquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya “the Board,” via email at pms@ppb.go.ke
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Medicine Quality Alert: Class I Medicine Recall of Flurasted 500 (5-Fluorouracil) Injection Batch no. HHP24017