Dovate Cream (Clobetasol Propionate)

Dovate Cream (Clobetasol Propionate)

 

Company name & Address:

 

Registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Recall date

Pharmacare Ltd t/a Aspen Pharmacare Building 12, Healthcare Park Woodlands Drive  

27/13.4.1/0316

 

E0012547

 

April 2026

 

25g

 

12 June 2024

 

Class III Type B

 

 

29 August 2024

 

Reason for recalls

This recall is initiated because of the compromised package integrity on some of the tubes. The tubes were damaged by packaging equipment during the packing process causing part of the upper portion of the tubes to split open.

 

Advice to HCPs/Distributors/Public

The company requested that you immediately return the affected batch of Dovate Cream 25g to your supplying 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: 29/08/2024
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance