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Recall one Batch of Vectibix 20mg/ml conc. solution for infusion

2023-05-08

Product Description :

 

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Vectibix 20mg/ml conc. solution for infusion

PANITUMUMAB        

16-475-13

1149838A

Amgen manufacturing limited.

Issue :

Saudi FDA has issued a recall one batch of Vectibix 20mg/ml conc. solution for infusion due to Metal Seal Crimp Defect of ampoule. Amgen manufacturing limited is voluntarily recalling the batch.

Recommendations :

For healthcare professionals:

  • Stop dispensing the above batch immediately. Embargo/Quarantine all remaining stock. Affected batches should be returned to the supplier.
  • Contact the recalling firm or Saudi FDA 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 one Batch of Vectibix 20mg/ml conc. solution for infusion