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Recall All batches of MOXICLAV 1 gm Film Coted Tablet

Recall All batches of MOXICLAV 1 gm Film Coted Tablet

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 MOXICLAV 1 gm Film Coted Tablet Amoxicillin, Clavulanic Acid 8-718-18 جميع التشغيلات حتى تاريخه Medochemie LTD

التصنيف
ملف
التاريخ
2023-04-20
اسم المستحضر
MOXICLAV 1 gm Film Coted Tablet
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب

<p><span><span><span>Saudi FDA issued Recall all batches of </span><span><span>MOXICLAV 1 gm Film Coted Tablet</span></span><span> due to the composition of outer coating of tablets in the marketed batches not matching the composition of batch used in the bioequivalence study that was submitted to the authority.</span></span></span></p>

التوصيات

<p><span><span><strong><span>For healthcare professionals, </span></strong><span>Stop dispensing the above product immediately. Embargo/Quarantine all remaining stock. Affected product 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 product, 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>