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Recall All Batches of 11 sterile pharmaceutical products manufactured by Saudi Pharmaceutical Industries

Recall All Batches of 11 sterile pharmaceutical products manufactured by Saudi Pharmaceutical Industries

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 Adijet 1 mg/ml Injection Adrenaline 1mg/ml 1304210679 جميع التشغيلات حتى تاريخه Saudi Pharmaceutical Industries, SPI EPINOR 1 mg/ml Injection Norepinephrine Bitartrate 1mg/ml 14-430-18 Ondex 2 mg...

التصنيف
ملف
التاريخ
2023-04-20
اسم المستحضر
11 Sterile pharmaceutical products manufactured by Saudi Pharmaceutical Industries
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب

<p dir="RTL" style="direction: ltr;"><span><span>Saudi FDA has issued a recall of all products above due to GMP non-compliance based on inspection observations during the visit that carried out at Saudi Pharmaceutical Industries, Saudi Arabia, which may affect the quality and safety of finished pharmaceutical product.</span></span></p>

التوصيات

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

<ul>
<li><span><span><span><span><span><span>Stop dispensing the above products immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.</span></span></span></span></span></span></li>
<li><span><span><span><span><span><span>Contact the recalling firm or Saudi FDA if you have any questions about the recall.</span></span></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 Saudi Vigilance either online or call center (Call 19999).</span></span></span></span></li>
</ul>