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Medicine Quality Alert: Class II Recall of several batches of Tenofovir Disoproxil Fumarate /Lamivudine/ Dolutegravir (300/300/50mg) manufactured by Universal Corporation Ltd

Universal Corporation Ltd has initiated a voluntary recall of specific batches of Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir tablets due to discoloration of the induction seals, black spots on the tablets, and cracked tablets.

From: Pharmacy and Poisons Board

Published: 07 December 2022

Recall Reference Number: REC/2022/09

Recall Classification: Class II

Recall Level: Retail/Facility Level

Company Name: Universal Corporation Ltd, Kenya

Product name: Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir

Active Pharmaceutical Ingredient: Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir (300/300/50mg)

 Affected Batches

 

Batch No

Manufacture Date

Expiry Date

Pack Size

1.     

5810848

20.05.2022

30.04.2024

90’s

2.     

5810847

01.04.2022

31.03.2024

90’s

3.     

5810846

16.05.2022

30.04.2024

90’s

4.     

5810845

14.04.2022

31.03.2024

90’s

5.     

5810844

16.05.2022

30.04.2024

90’s

6.     

5810833

11.05.2022

30.04.2024

90’s

7.     

5810832

04.05.2022

30.04.2024

90’s

8.     

5810831

01.05.2022

30.04.2024

90’s

9.     

5810830

02.05.2022

30.04.2024

90’s

10.  

5810611

21.03.2022

29.02.2024

90’s

11.  

5810612

25.03.2022

29.02.2024

90’s

12.  

5810760

14.04.2022

31.03.2024

90’s

13.  

5810761

14.04.2022

31.03.2024

90’s

14.  

5810762

16.04.2022

31.03.2024

90’s

15.  

5810763

01.04.2022

31.03.2024

90’s

16.  

5810764

01.04.2022

31.03.2024

90’s

17.  

5810797

02.05.2022

30.04.2024

90’s

18.  

5810798

02.05.2022

30.04.2024

90’s

19.  

5810799

01.05.2022

30.04.2024

90’s

20.  

5810800

04.05.2022

30.04.2024

90’s

21.  

5810801

04.05.2022

30.04.2024

90’s

22.  

5810812

14.04.2022

31.03.2024

90’s

23.  

5810813

14.04.2022

31.03.2024

90’s

24.  

5810814

16.04.2022

31.03.2024

90’s

25.  

5810815

01.04.2022

31.03.2024

90’s

26.  

5810816

01.05.2022

30.04.2024

90’s

27.  

5810829

02.05.2022

30.04.2024

90’s

28.  

5809767

01.08.2021

31.07.2023

90’s

29.  

5809768

20.08.2021

31.07.2023

90’s

30.  

5810264

01.01.2022

31.12.2023

90’s

31.  

5810859

24.05.2022

30.04.2024

90’s

32.  

5810860

24.05.2022

30.04.2024

90’s

33.  

5810861

24.05.2022

30.04.2024

90’s

34.  

5810862

21.03.2022

29.02.2024

90’s

35.  

5810863

26.05.2022

30.04.2024

90’s

36.  

5810922

14.04.2022

31.03.2024

90’s

37.  

5810923

01.05.2022

30.04.2024

90’s

38.  

5810924

01.06.2022

31.05.2024

90’s

39.  

5810935

01.04.2022

31.03.2024

90’s

40.  

5810936

01.04.2022

31.03.2024

90’s

41.  

5810937

02.05.2022

30.04.2024

90’s

42.  

5810938

01.06.2022

31.05.2024

90’s

43.  

5810939

08.06.2022

31.05.2024

90’s

44.  

5810950

08.06.2022

31.05.2024

90’s

45.  

5810951

13.06.2022

31.05.2024

90’s

46.  

5810952

13.06.2022

31.05.2024

90’s

47.  

5810953

13.06.2022

31.05.2024

90’s

48.  

5810954

13.06.2022

31.05.2024

90’s

49.  

5810973

13.06.2022

31.05.2024

90’s

50.  

5810974

01.05.2022

30.04.2024

90’s

51.  

5810975

02.05.2022

30.04.2024

90’s

52.  

5810976

02.05.2022

30.04.2024

90’s

53.  

5810977

01.05.2022

30.04.2024

90’s

54.  

5810983

04.05.2022

30.04.2024

90’s

55.  

5811074

04.05.2022

30.04.2024

90’s

56.  

5811075

14.04.2022

31.03.2024

90’s

57.  

5811076

14.04.2022

31.03.2024

90’s

58.  

5811077

16.04.2022

31.03.2024

90’s

59.  

5811078

01.04.2022

31.03.2024

90’s

60.  

5811079

01.06.2022

31.05.2024

90’s

61.  

5810920

31.05.2022

30.04.2024

30’s

62.  

5810921

31.05.2022

30.04.2024

30’s

63.  

5810922

31.05.2022

30.04.2024

30’s

64.  

5809767

01.08.2021

31.07.2023

30’s

65.  

5809768

20.08.2021

31.07.2023

30’s

66.  

5810905

27.05.2022

30.04.2024

30’s

67.  

5810906

27.05.2022

30.04.2024

30’s

68.  

5810907

30.05.2022

30.04.2024

30’s

69.  

5810908

31.05.2022

30.04.2024

30’s

70.  

5810909

31.05.2022

30.04.2024

30’s

Brief description of the problem

Universal Corporation Ltd has initiated a voluntary recall of the affected batches of Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir up to the retail/hospital pharmacy level. The product is being recalled due to several market complaints of discolored induction seals, black spots, and cracked tablets.

Action for healthcare professionals

You are advised to immediately quarantine and stop supplying all remaining stock of the affected batches of the product. Universal Corporation Ltd will contact you to arrange the return of the impacted batches of the product.

Action for patients and caregivers

Patients who have been prescribed the impacted patients should seek medical advice from healthcare providers.

Further Information

For stock inquiries please contact Universal Corporation Limited by email: info@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 Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine Quality Alert: Class II Recall of several batches of Tenofovir Disoproxil Fumarate/Lamivudine/Dolutegravir (300/300/50mg) manufactured by Universal Corporation Ltd