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Recall of multiple batches of the products: VISIPAQUE 320mg/mL and OMNIPAQUE 350mg/ml

2026-04-05

Product 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,

  1. Consult your healthcare provider prior to discontinuing use of the affected batches, or for any health concerns.
  2. Contact the recalling firm or SFDA if you have any questions about the recall.
  3. 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).


Recall of multiple batches of the products: VISIPAQUE 320mg/mL and OMNIPAQUE 350mg/ml