Coralan 7.5 mg Tablets (Ivabradine 7.5mg)

Coralan 7.5 mg Tablets (Ivabradine 7.5mg)

 

Company name & Address:

 

Registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Recall date

Servier (Pty) Ltd 3rd Floor, Building J, Hertford Office Park, 90 Bekker Road, Vorna Valley, Midrand, 1686  

A39/7.1.4/0411

719715

709702

705182

701085

705921

715957

697702

January 2026

April 2025

April 2025

March 2025

April 2025

November 2025

December 2024

 

56’s

 

20 April 2024

22 March 2023

22 March 2023

02 September 2022

22 March 2023

27 July 2023

25 July 2023

 

Class II Type B

 

22 July 2024

 

Reason for recalls

This recall is initiated as a result of a product packaging mistake lodged with Servier Laboratories. Some of the cartons (box) are incorrectly printed on the side panel, but the tablets inside the blisters are the correct tablets according to the carton.

 

Advice to HCPs/Distributors/Public

Please check if you have the above batches in stock and kindly return them to us. Please can you immediately return the affected boxes of Coralan 7,5 mg from Batch 719715, 709702, 705182, 701085, 705921, 715957, 697702 to your wholesaler for a full credit.


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: 22/07/2024
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance