27 Apr Novomix Injection 30 Penfil, 3 ml (100 units of Insulin Aspart)
| Company name & Address: |
registration number |
Batch number(s) |
Expiry date |
Pack size |
First date of release |
Re-call Classification |
Recall date
|
| Novo Nordisk (Pty) Ltd,10 Marion Office Park, Building C1,150 Rivonia Road, Sandton |
35/21.1/0031 |
NR7SE13 |
June.2025 |
5’s
|
16.Nov.2023 |
Class II Type B
|
08.Jan.2024 |
Reason for recall
This recall was initiated due to incidents of cracked cartridges found in cartridge batches from cartridge supplier and used for filling of the insulin product.
Advice to HCPs/Distributors/Public:
The company requested their clients to refrain from selling any of the affected batch of Novomix® 30 Penfill® and to return them to their supplying warehouse or distributor with immediate effect for 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.