27 Apr Amuco 600 Effervescent Tablet (Acetylcysteine 600mg)
| 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, South Africa |
47/10.2.2/0477 |
42332, 42333, 42334, 42386, 42387, 42388, 42389 (see customer letter for more batches) |
May.2024 |
1 tube of 10 tablets |
Sep.2023 |
Class III Type C |
24.May.2023 |
Reason for recall
The recall was initiated because some of the containers possess defective primary packaging, resulting in the loosening of the seal on certain packages. The company confirmed that this faulty seal, combined with the hygroscopic nature of the product, causes the product to become moist.
Advice to HCPs/Distributors/Public:
The company requested their clients to immediately return all units on hand of the affected batches to their 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.