Issue :

Saudi FDA issued Recall two batches of Brukinsa , 80mg Capsules due to not comply with the approved specifications . Beigene International GmbH is voluntarily recalling batches.

Recommendations :

For healthcare professionals, Stop dispensing the above batch immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.

for patients

• Consult your healthcare provider prior to discontinuing use of the affected batch, or for any health concerns.
• Contact the recalling firm or Saudi FDA if you have any questions about the recall.
• Adverse reactions or quality problems experienced with the use of this product may be reported to Saudi Vigilance either online or call center (Call 19999).