27 Apr Haemosolvate® Factor VIII 500 IU5ml
|
Company name & Address: |
Registration number |
Batch number(s) |
Expiry date |
Pack size |
First distributed |
Re-call Classification |
Recall date |
Published date |
| National Bioproducts Institute NPC
10 Eden Road, Pinetown, 3610 |
Y/30.3/292 |
V8T1613 |
Sep 2027 |
500 IU |
10 January 2025 |
Class III Type C |
13.Feb.2025 |
10 March 2025 |
Brief description of the problem (reason for recall)
An inadvertent inclusion of plasma from an unapproved supplier in the formulation, which was not detected at the time of batch release.
Advice for health professionals and distributors
We request that you refrain from selling the affected batch of Haemosolvate Factor VIII 500 IU. NBI will collect all your stock which will be replaced with another batch.
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.