Recall two batches of pms-AMITRIPTYLINE 50mg TABS
2024-02-28
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer pms-AMITRIPTYLINE 50mg TABS Amitriptyline غير مسجل 634972 637195 Pharmascience Inc
<p><span><span>Saudi FDA issued Recall two batches of pms-AMITRIPTYLINE 50mg TABS due to presence of (N-nitrosodimethylamine (and (N-nitroso-nortriptyline ( impurities. Pharmascience Inc. is voluntarily recalling the affected batches.</span></span></p>
<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>
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