ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)

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27 Apr ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)

Posted at 12:41h in by

Company name &

Address

  

registration number

  

Batch number

  

Expiry date

  

Pack size

  

First distributed

  

Re-call Classification

  
Re-call Date
UNICORN PHARMACEUTICALS (PTY) LTD

CNR SEARLE AND PONTAC STREETS, CAPE TOWN, 8001

  

50 mg: 46/7.1.3/0714

  

LS220001A

  

July-2022

  

30

  

12/11/2020

  

Class II Type B

  

31 August 2021
 

100 mg: 46/7.1.3/0715

  

LS320002A

  

June-2022

  

30

  

30/11/2020

  

Class II Type B

  

31 August 2021

 

Reason for recall

The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].

 

Advice to HCPs/Distributors/Public:

Stock is blocked for distribution and immediate quarantine of stock is initiated in Distribution and Wholesales. Quantity of stock affected to be confirmed. Return any of the above products to your United Pharmaceutical Distributor (UPD) wholesaler.

 

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.

Download latest version
Version: 1
Date Updated: 31/08/2021
File Type: www
Category: Product Recall
Unit: Regulatory Compliance