Oranix Solution (oral rinse) (Benzydamine HCl 22,5 mg/15 ml; Chlorhexidine gluconate 18,0 mg/15 ml)

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27 Apr Oranix Solution (oral rinse) (Benzydamine HCl 22,5 mg/15 ml; Chlorhexidine gluconate 18,0 mg/15 ml)

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Company name & Address:  

registration number

  

Batch number(s)

  

Expiry date

  

Pack size

  

First distributed

  

Re-call Classification

  

Re-call Date
iNova Pharmaceuticals (Pty) Ltd

15E Riley Road, Bedfordview, 2007 South Africa

  

34/16.4/0391

  

126189

  

11/2023

  

200 ml

  

13.12.2021

  

Class III Type C

 28 January 2022

 

Reason for recall

This product is being recalled due to a complaint relating to quality defect: The assay of the active pharmaceutical ingredient, chlorhexidine gluconate, is below approved specification and the efficacy of this product cannot be guaranteed, (Assay limit of Chlorhexidine Gluconate ut of specification).

 

Advice to HCPs/Distributors/Public:

Immediate batch tracing, quarantine of stock from all distributors & their clients, immediate notification to recall the batches

 

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: 28/01/2022
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance