OsvaRen 435mg_235 film coated tablets

Home > OsvaRen 435mg_235 film coated tablets

27 Apr OsvaRen 435mg_235 film coated tablets

Posted at 12:52h in by

OsvaRen 435mg_235 film coated tablets

Company name & Address:  

registration number

  

Batch number(s)

  

Expiry date

  

Pack size

  

First distributed

  

Re-call Classification

  

Re-call Date
Fresenius Medical Care South Africa (PTY) Ltd. 9 Galaxy Ave. Frankenwald Sandton 2090, South Africa  

45/24/0919

  

ZC015 200, ZOAK08100, ZOAK04 200, ZC016100, ZOAK04300, ZOAK05200,

ZOAK08300

  

2.2021 (old), 30.07.2022

(new)

9.2021 (old), 31.07.2022

(new)

2.2021 (old),12.20 21

(new)

  

180s

  

04/10/2019

  

Class III Type B

 22 April 2022

 

Reason for recall

This product is being recalled due to a complaint relating to quality defect: Complaint on the final product packaging of Osvaren 435mg/ 235m g film- coated tablets (a secondary label with new expiry date affixed on top of the originally printed one).

 

Advice to HCPs/Distributors/Public:

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

 

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: 22/04/2022
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance