Recall of multiple batches of the product ARANESP 500MCG/1ML PRE-FILLED SYRINGE
2026-08-09
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer ARANESP 500MCG/1ML PRE-FILLED SYRINGE DARBEPOETIN ALFA 12-475-06 1189992A 1190934A AMGEN MANUFACTURING LIMITED, United States
التصنيف
ملف
التاريخ
2026-08-05
اسم المستحضر
ARANESP 500MCG/1ML PRE-FILLED SYRINGE
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب
SFDA has issued a recall of multiple batches of ARANESP 500 mcg/1 mL Pre-filled Syringe. The defect was identified as an Out-of-Specification (OOS) result, manifested by the presence of visible particles during the product's stability study at the 18-month stability time point. which may affect the quality and safety of the product.
التوصيات
For healthcare professionals: Stop dispensing the 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 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).
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