Recall ALL batches of Oxbryta 500 mg Film-coated tablet
2024-12-08
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer Oxbryta VOXELOTOR 1903233380 ALL Batches PATHEON INC
التصنيف
ملف
التاريخ
2024-09-28
اسم المستحضر
Oxbryta
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب
SFDA has issued a recall all batches of Oxbryta products due to on a review and analysis of the data that is currently available from ongoing clinical trials and registry studies that indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved indication. Pfizer is voluntarily recalling the above batches
التوصيات
For healthcare professionals: Stop dispensing the affected batches immediately. Embargo/Quarantine all remaining stock. Affected batches should be returned to the supplier.
For patients,
- Consult your healthcare provider prior to discontinuing use of the affected batches, or for any health concerns.
- Contact the recalling firm or SFDA 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).
评论与建议
如对政府服务有任何咨询或意见,请填写所需信息。