Medicine Quality Alert: Class II Medicine Recall of Medzol (Metronidazole 400mg) Tablets, Batch Number 230940
The Pharmacy and Poisons Board has mandated Topstone Pharma Limited, to conduct an urgent recall of Medzol (Metronidazole 400mg) Tablets Batch No. 230940
From: Pharmacy and Poisons Board
Date of Recall Initiation: 11th March 2025
Recall Reference Number: REC/2025/007
Recall Classification: Class II
Recall Level: Retail/Facility Level
Local Technical Representative: Topstone Pharma Limited.
Manufacturer: Shanxi Xinyitong Pharmaceutical Co., Ltd, China
Product name: Medzol
Active Pharmaceutical Ingredient: Metronidazole 400mg
Affected Counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
230940 | 09/2023 | 09/2026 | 100’s |
Brief description of the problem
The Pharmacy and Poisons Board has mandated Topstone Pharma Limited, to conduct an urgent recall of Medzol (Metronidazole 400mg) Tablets Batch No. 230940, due to out-of-specification results on the test for Uniformity of weight.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Topstone Pharma Limited 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 Topstone Pharma Limited at topstonepharma2022@gmail.com or mhtemypaul@gmail.com or via telephone: +254 768 217670 and +254 716 338 642
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
- Mobile application: mPvERS both Android and iOS
For any further information please contact the post-marketing surveillance unit at the Pharmacy and Poisons Board by email: pms@ppb.go.ke
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Medicine Quality Alert: Class II Medicine Recall of Medzol (Metronidazole 400mg) Tablets, Batch Number 230940