07 May Halaven (Eribulin)
| Company name & Address: | registration number | Batch number(s) | Expiry date | Pack size | First release date | Re-call Classification | Recall date |
| Eisai Pharmaceuticals Africa (Pty) Ltd
2nd Floor, Golden Oak House, Ballyoaks Office Park, 35 Ballyclare Drive, Bryanston |
48/26/0047 |
148482 |
May 2028 |
1 vial |
06 December 2024 |
Class II Type C |
04 May 2026 |
Brief description of the problem (reason for recall)
This recall is initiated due to Out of specification low assay results (88.6% vs specification of 95.0-105%) was identified for Eribulin batch.
Advice for health professionals and distributors:
Eisai requests that you refrain from selling any of the affected batch of Halaven 0.88mg/2ml INJ and return them to our distributor with immediate effect at:
DP World (was Imperial Health Sciences)
012 621 4300
All returned stock of this batch number will be replaced, free of charge, or a credit will be
passed.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
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.