Medicine Quality Alert: Class II Recall of Fluconazole 200mg Tablets manufactured by Universal Corporation Ltd
The Pharmacy and Poisons Board has initiated a mandatory recall of Fluconazole 200mg tablets (a list of batches is enclosed in the table below) manufactured by Universal Corporation Ltd due to white discoloration on pink tablets and dark stains on PVC and Unit boxes
From: Pharmacy and Poisons Board
Published: 4th May 2023
Recall Reference Number: REC/2023/005
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Universal Corporation Ltd, Kenya
Product name: Fluconazole 200mg Tablets
Active Pharmaceutical Ingredient: Fluconazole
Affected Counties: All
Affected Batches
| Batch Number | Date Of Manufacture | Date Of Expiry | Pack Size |
1. | 5811394 | 01.09.2022 | 31.08.2025 | 100 tablets |
2. | 5811393 | 01.09.2022 | 31.08.2025 | 100 tablets |
3. | 5811392 | 01.09.2022 | 31.08.2025 | 100 tablets |
4. | 5811391 | 01.09.2022 | 31.08.2025 | 100 tablets |
5. | 5811390 | 01.09.2022 | 31.08.2025 | 100 tablets |
6. | 5811185 | 27.07.2022 | 26.06.2025 | 100 tablets |
7. | 5811183 | 27.07.2022 | 26.06.2025 | 100 tablets |
8. | 5811184 | 27.07.2022 | 26.06.2025 | 100 tablets |
9. | 5811182 | 27.07.2022 | 26.06.2025 | 100 tablets |
10. | 5811125 | 09.07.2022 | 30.06.2025 | 100 tablets |
11. | 5811123 | 09.07.2022 | 30.06.2025 | 100 tablets |
12. | 5811124 | 09.07.2022 | 30.06.2025 | 100 tablets |
13. | 5811122 | 09.07.2022 | 30.06.2025 | 100 tablets |
14. | 5811121 | 09.07.2022 | 30.06.2025 | 100 tablets |
15. | 5811120 | 09.07.2022 | 30.06.2025 | 100 tablets |
16. | 5810962 | 07.06.2022 | 30.05.2025 | 100 tablets |
17. | 5810961 | 07.06.2022 | 30.05.2025 | 100 tablets |
18. | 5810959 | 07.06.2022 | 30.05.2025 | 100 tablets |
19. | 5810960 | 07.06.2022 | 30.05.2025 | 100 tablets |
20. | 5810958 | 07.06.2022 | 30.05.2025 | 100 tablets |
21. | 5810320 | 01.02.2022 | 31.01.2025 | 100 tablets |
22. | 5810319 | 01.02.2022 | 31.01.2025 | 100 tablets |
23. | 5810318 | 01.02.2022 | 31.01.2025 | 100 tablets |
24. | 5810317 | 01.02.2022 | 31.01.2025 | 100 tablets |
25. | 5810316 | 01.02.2022 | 31.01.2025 | 100 tablets |
26. | 5810315 | 01.02.2022 | 31.01.2025 | 100 tablets |
27. | 5810022 | 01.11.2021 | 31.10.2024 | 100 tablets |
28. | 5810021 | 01.11.2021 | 31.10.2024 | 100 tablets |
29. | 5809602 | 01.08.2021 | 31.07.2024 | 100 tablets |
Brief description of the problem
The Pharmacy and Poisons Board has mandated Universal Corporation Ltd to initiate an urgent recall of specific batches of Fluconazole 200mg, following several market complaints of white discoloration on pink tablets and dark stains on the Polyvinyl chloride (PVC) blisters and unit boxes.
Action for healthcare professionals
You are advised to immediately quarantine all remaining stock and stop further distribution and sale of the impacted batches. Universal Corporation Ltd will contact you to arrange the return of the product.
Action for patients and caregivers
No further action is required by patients as this is a Retail/hospital Pharmacy level recall. Patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.
Further Information
For stock inquiries please contact Universal Corporation Limited by email: info@ucl.co.ke and caroline.kimani@ucl.co.ke or via telephone on +254 722707126, +254 721922280, +254 734513075, +254 738279223, +254 738279224, +254(0) 202693836, +254(0) 202693835, +254(0) 202693834
You are encouraged to promptly report any cases of adverse reactions and suspected substandard or falsified products to the nearest healthcare facility or through the following channels:
- https://pv.phorg/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 Recall of Fluconazole 200mg Tablets manufactured by Universal Corporation Ltd