Product Description :

Issue :

SFDA has issued a recall of multiple batches of ARANESP 500 mcg/1 mL Pre-filled Syringe. The defect was identified as an Out-of-Specification (OOS) result, manifested by the presence of visible particles during the product's stability study at the 18-month stability time point. which may affect the quality and safety of the product.

Recommendations :

For healthcare professionals: Stop dispensing the batch immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.

For patients,

1. Consult your healthcare provider prior to discontinuing use of the affected batch, 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).