Recall one Batch of Vectibix 20mg/ml conc. solution for infusion
2023-05-08Product 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).