Product Description :

Issue :

SFDA has issued a recall all batches of Andexxa 200 mg powder for solution for infusion due to The potential risks associated with the use of the product outweigh its anticipated benefits, as the scientific evaluation of the available evidence and data has demonstrated an increased risk of thrombotic events associated with its use compared to the available therapeutic alternatives.

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 product, 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).