Medicine Quality Alert: Class II Medicine Recall of Phenysod (Phenytoin Sodium) Injection Batch Number H24119
Zawadi Healthcare Ltd has initiated an urgent voluntary recall of Phenysod (Phenytoin Sodium) Injection Batch Number H24119 Manufactured by Hiral Laboratories Ltd.
From: Pharmacy and Poisons Board
Published: 22nd October 2024
Recall Reference Number: REC/2024/028
Recall Classification: Class II
Recall Level: Retail/Facility level
Local Technical Representative (LTR): Zawadi Healthcare Ltd
Manufacturer: Hiral Laboratories Ltd, India
Product name: Phenysod
Active Pharmaceutical Ingredient: Phenytoin Sodium Injection
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
H24119 | 04/2024 | 03/2026 | 5x5ml |
Brief description of the problem
The product is being recalled due to a market complaint on formation of a precipitate when mixed with normal saline for infusion.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Zawadi Healthcare 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.
Further Information
For inquiries about consignments of the impacted batch, please contact Zawadi Healthcare Ltd at: bhatt@zawadihealthcare.com or sales@zawadihealthcare.com or by Telephone at: +254 733 882 277, +254 788 655 843
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 Phenysod (Phenytoin Sodium) Injection Batch Number H24119