Recall of multiple batches of the OMNIPAQUE 350mg/ml
2026-04-20
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer OMNIPAQUE 350MG/ML IOHEXOL 46-261-22 17359070 17402903 17406203 17417180 GE HEALTHCARE
التصنيف
ملف
التاريخ
2026-04-05
اسم المستحضر
VISIPAQUE 320mg/mL and OMNIPAQUE 350mg/ml
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب
SFDA has issued a recall of multiple batches of OMNIPAQUE 350mg/ml due to presence of dark particles adhered inside the bottle, which may affect the safety and quality of the product.
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).
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