Recall two batches of Brukinsa , 80mg Capsules
2024-09-04
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
التصنيف
ملف
التاريخ
2024-08-26
اسم المستحضر
Brukinsa
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب
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.
التوصيات
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).
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