Recall of batch MA04M63 from the product: GASTROGRAFIN 76-ORAL AQUEOUS SOLN

Recall of batch MA04M63 from the product: GASTROGRAFIN 76-ORAL AQUEOUS SOLN

2026-03-17

Product Description :

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

GASTROGRAFIN 76-ORAL AQUEOUS SOLN

Diatrizoate Meglumine

0505245248

MA04M63

Berlimed S.A.

Issue :

SFDA has issued a recall of batch MA04M63 from the product: Gastrografin 76-oral aqueous solution due to detection of positive results for the impurity N-Nitroso-Meglumine exceeding the permitted limit, which may affect the safety and quality of the product.

Recommendations :

For healthcare professionals: Stop dispensing the all 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 batch MA04M63 from the product: GASTROGRAFIN 76-ORAL AQUEOUS SOLN