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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:

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