27 Apr 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.