Recall of multiple batches of the products: VISIPAQUE 320mg/mL and OMNIPAQUE 350mg/ml
2026-04-05Product Description :
|
الاسم التجاري |
الاسم العلمي |
رقم التسجيل |
رقم التشغيلة المتأثرة |
الشركة الصانعة |
|
Trade Name |
Scientific Name |
Register Number |
Affected batch number |
Manufacturer |
|
VISIPAQUE 320MG/ML |
IODIXANOL |
39-315-12 |
17303283 |
GE HEALTHCARE |
|
OMNIPAQUE 350MG/ML |
IOHEXOL |
46-261-22 |
17359070 17402903 17406203 17417180 |
Issue :
SFDA has issued a recall of multiple batches of the products: VISIPAQUE 320mg/mL and OMNIPAQUE 350mg/ml due to presence of dark particles adhered inside the bottle, which may affect the safety and quality of the product.
Recommendations :
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).