27 Apr Aflibercept 40mg/ml Intravitreal Injection (Aflibercept 40mg/ml)
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First distributed | Re-call Classification | Recall date |
| Eurolab ASU, a division of Eurolab (Pty) Ltd, Units 5&6, K101 Business Park, Capital Hill Commercial Estate, Cnr Le Roux Avenue and K101 Old Pretoria, Main Road, Halfway House, Midrand, 1685 |
N/A |
AFL031023
AFL0310723 AFL0310822 AFLO310921 AFL0311023 |
11.Apr.2025
21.Apr.2025 21.Apr.2025 10.May.2025 18.May.2025 |
50ul |
27 February 2025
07.March.2025 13.March.2025 27.March.2025 04.April.2025 |
Class II Type C |
16.May.2025 |
Brief description of the problem (reason for recall)
This recall is initiated due to contravention of Section 14 of the Medicines and Related Substances Act, 101 of 1965, as amended and contravention to the license conditions.
Advice for health professionals and distributors
We request that you refrain from selling the affected batches of Aflibercept. Eurolab ASU will make the necessary arrangements for collection of all your stock currently on hand.
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.