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Recall some batches of Renis Capsule

Recall some batches of Renis Capsule

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 RENIS 12.5 MG CAPSULE SUNITINIB 299-334-19 1449 1460 1461 The Arab Pharmaceutical Manufacturing PSC Sult RENIS 25 MG CAPSULE 300-334-19 1462

التصنيف
ملف
التاريخ
2023-08-15
اسم المستحضر
RENIS CAPSULE
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب

<p><span><span><span>Saudi FDA issued Recall some batches of Renis Capsule due to out of specification results in </span><span><span>microbial contamination test ( Total Viable Aerobic Count-Fungi )</span></span><span>. </span><span>Jazeera Pharmaceutical Industries (JPI) </span><span>is voluntarily recalling batches.</span></span></span></p>

التوصيات

<p><span><span><strong><span>For healthcare professionals, </span></strong><span>Stop dispensing the above batches immediately. Embargo/Quarantine all remaining stock. Affected batches should be returned to the supplier.</span></span></span></p>

<p><span><span><strong><span>for patients </span></strong></span></span></p>

<ul>
<li><span><span><span><span>Consult your healthcare provider prior to discontinuing use of the affected batches, or for any health concerns.</span></span></span></span></li>
<li><span><span><span><span>Contact the recalling firm or Saudi FDA if you have any questions about the recall.</span></span></span></span></li>
<li><span><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></span></li>
</ul>