ETORICOXIB 60 AUSTELL (ETORICOXIB 60,0 mg)

ETORICOXIB 60 AUSTELL (ETORICOXIB 60,0 mg)

 

Company name & Address:

 

Registration number

 

Batch number(s)

 

Expiry date

 

Pack size

 

First distributed

 

Re-call Classification

 

Recall date

Date Published
Austell Pharmaceuticals. 1 Sherborne Road, Parktown, 2193.  

49/3.1/0989

 

AGT4001

 

Feb

2028

 

28’s

 

May 2024

 

Class III Type B

 

7 November 2024

21 November 2024

 

Brief description of the problem (reason for recall)

This recall follows a recent internal quality review which identified a deviation in the supplier as well as the Transfer of Applicant pending to Austell Pharmaceuticals.

 

Advice for health professionals and distributors

Further use or distribution of the above product batches must cease immediately.

Austell requests that you immediately return all units on hand of the batch mentioned

above to your supplying wholesaler or distributor 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: 21/11/2024
File Type: www
Category: Product Recall
Unit: General ECTD & human medicines, Regulatory Compliance