Medicine Quality Alert: Class II Medicine Recall of Zeondern Injection (Ondansetron Hydrochloride 8mg/4ml), Batch No. ZOU-2401
The Pharmacy and Poisons Board has mandated the recall of Zeondern (Ondansetron Hydrochloride 2mg) Injection, Batch No. ZOU-2401, due to failure to comply with the specifications of physical appearance.
From: Pharmacy and Poisons Board
Date of Recall Initiation: 17th July 2025
Recall Reference Number: REC/2025/024
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Systochem Laboratories Limited, India
Local Technical Representative: Zengenta Pharmaceuticals Ltd
Product name: Zeondern
Active Pharmaceutical Ingredient: Ondansetron Hydrochloride 8mg/4ml
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
ZOU-2401 | 08/2024 | 07/2027 | 4ml |
Brief description of the problem
The product is being recalled due to non-compliance with physical appearance specifications, following an investigation into a market complaint regarding a change in the product’s color.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Zengenta Pharmaceuticals Ltd, Kenya, who will contact healthcare professionals directly to arrange the return.
Action for patients and carers
No further action is required by patients as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall.
Further Information
For medical information inquiries, please contact Zengenta Pharmaceuticals Ltd, Kenya, at scola@zengenta.co.ke, or via telephone +254 020 440 5811 / 12, +254 721 51 70 74
Promptly report any cases 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
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 Recall of Zeondern (Ondansetron Hydrochloride 2mg) Injection, Batch No. ZOU-2401