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Recall two batches of Brukinsa , 80mg Capsules

2024-08-26

Product Description :

 

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Brukinsa , 80mg Capsules

Zanubrutinib

0811211272

2046980

CATALENT

1995863

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).


Recall two batches of Brukinsa , 80mg Capsules