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

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

icon 2024-02-28

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.

التصنيف
ملف
التاريخ
2023-05-08
اسم المستحضر
Vectibix 20mg/ml conc. solution for infusion
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب

<p><span><span>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.</span></span></p>

التوصيات

<p><span><span><strong><span>For healthcare professionals: </span></strong></span></span></p>

<ul>
<li><span><span><span>Stop dispensing the above batch immediately. Embargo/Quarantine all remaining stock. Affected batches should be returned to the supplier.</span></span></span></li>
<li><span><span><span>Contact the recalling firm or Saudi FDA if you have any questions about the recall.</span></span></span></li>
<li><span><span><span>Adverse reactions or quality problems experienced with the use of this product may be reported to </span><a href="https://ade.sfda.gov.sa/"><span>Saudi Vigilance</span></a><span> either online or call center (Call 19999).</span></span></span></li>
</ul>