27 Apr Acenten 20/12,5 mg Tablets (Enalapril Maleate 20 mg and Hydrochlorothiazide 12.5mg)
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
| Austell Pharmaceuticals 1 Sherborne Road Parktown 2193 |
49/7.1.3/1087 |
JTU022001
JTU022002 |
11/2024 |
30’s |
29 March 2023 |
Class II Type B |
10 January 2024 |
Reason for recalls
The product is being recalled due to a noted out of specification which may result in sub-therapeutic dosing.
Advice to HCPs/Distributors/Public
Further use or distribution of the above product batches must cease immediately. Austell requests that you immediately return all units on hand of the batches 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.