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Recall ALL batches of Oxbryta 500 mg Film-coated tablet

2024-09-28

Product Description :

 

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Oxbryta

VOXELOTOR

1903233380

ALL Batches

PATHEON INC

Issue :

SFDA has issued a recall all batches of Oxbryta products due to on a review and analysis of the data that is currently available from ongoing clinical trials and registry studies that indicate the overall benefit of Oxbryta no longer outweighs the risk in the approved indication. Pfizer is voluntarily recalling the above batches

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).


Recall ALL batches of Oxbryta 500 mg Film-coated tablet