Mislabelling of Sanofi Eloctate Packaging (1000IU, 2000IU, 3000IU)

The NBA has been informed of product mislabelling on Sanofi Eloctate packaging for presentations of 1000IU, 2000IU and 3000IU.

The mislabelled packaging incorrectly states the active ingredient of Eloctate (efmoroctocog alfa (rhu)) as eftrenonacog alfa (rhu). The brand name ‘Eloctate’ is correct.

On the packaging of the 3000IU box, the strength is incorrectly stated as 2000IU next to the active ingredient name.

The vial strengths inside the packaging of all affected Eloctate presentations is correct. This error has no impact on product quality.

The TGA has provided directions on what to do if you have received any of the affected
products:

• Inspect your stock immediately and confirm if you have the impacted batches.
• Affected product in the market may continue to be used in the treatment of haemophilia A, however, customers should maintain an awareness of this labelling error, as described above. Patients and HCPs should refer to the vial label and product leaflet for the accurate information.
• If you have supplied or transferred any affected product to any patients or other organisations, provide them with a copy of this letter immediately.
• DHL will contact you to confirm receipt of this Urgent Product Alert letter, even if you do not have any affected stock.
• Ensure relevant staff members are informed of this product alert.
• Place this letter in a prominent position for at least one month.
• If you have any questions or concerns about this matter, please contact the TGA on 1800 818 806.