Co-Irbewin 300/12.5 mg, Tablets (Irbersatan &hydrochlorothiazide) and Irbewin 150 mg Tablets (irbersatan)

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27 Apr Co-Irbewin 300/12.5 mg, Tablets (Irbersatan &hydrochlorothiazide) and Irbewin 150 mg Tablets (irbersatan)

Posted at 12:48h in by
 

Company name & Address:

  

registration number

  

Batch number

  

Expiry date

  

Pack size

  

First distributed

  

Re-call Classification

  

Re-call Date
 

 

 

Sanofi-Aventis South Africa, 2 Bond Street Grand Central Ext. 01 Midrand 1685.

  

40/7.1.3/0287

  

AA550, AA507

  

August 2023

  

30

  

28 May 2020

  

Class II Type B

 27 October 2021
 

40/7.1.3/0288

  

AA406

  

September 2023

  

30

  

12 February 2021

  

Class II Type B

 27 October 2021

 

Reason for recall

These products are being recalled due to quality defect: Presence of impurity, also known as GTI 2 (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole – CAS 152708-24-2) is formed during the manufacture of the active ingredient.

 

Advice to HCPs/Distributors/Public:

 Stock is blocked for distribution and immediate quarantine of stock is initiated.

 

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: 27/10/2021
File Type: www
Category: Product Recall
Unit: Regulatory Compliance