Recall of batch No. 148318 of the product: halaven
2026-07-02
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer HALAVEN ERIBULIN MESILATE 1301268896 148318 BSP PHARMACEUTICALS
التصنيف
ملف
التاريخ
2026-05-07
اسم المستحضر
Halaven 0.44mg/ml vial
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب
SFDA has issued a recall of batch No. 148318 of the product: Halaven 0.44mg/ml vial due to out-of-specification (OOS) results identified in the assay test, which may affect the safety, efficacy, and quality 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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