Arthrexin 25 capsules (indomethacin 25mg)

Arthrexin 25 capsules (indomethacin 25mg)

Company name & Address:  

registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Recall date

Pharmacare Limited t/a Aspen Pharmacare, Healthcare Park, Woodlands Drive, Woodmead, Sandton 2196, South Africa  

K/3.1/285

   P0003739  

Jan.2025

 

100’s

 

Sep.2023

 

Class III Type C

 

05.Feb.2024

 

Reason for recall

The recall was initiated because of an error of incorrect labelling found on some containers. The complainant (pharmacy) found Arthrexin 25 mg capsules in a container labelled as Arthrexin 50 mg capsules.

 

Advice to HCPs/Distributors/Public:

The company requested their clients to immediately return all unit containers to their wholesaler or distributor for a full credit, without delay.

 

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was 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: 05/02/2024
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance