Recall batches of Apo-Amitriptyline 10 Mg and 25mg FCT
2024-12-08
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer Apo-Amitriptyline 10 Mg FCT Amitriptyline غير مسجل RN6384 TA6008 TF8586 TW2842 Apotex Inc Apo-Amitriptyline 25 mg FCT TA6061
التصنيف
Health practitioners
التاريخ
2024-10-31
اسم المستحضر
Apo-Amitriptyline 10 Mg and 25mgFCT
نوع المستحضر
Medicine Product
اجراء الاستدعاء
Wholesale level
مستوى الاستدعاء
Retail level
سبب السحب
Saudi FDA issued a recall of the mentioned batches of Apo-Amitriptyline 10 and 25mg Mg FCT due to the chemical impurities (Nitrosamines) exceeded the permissible limit. Apotex Inc is voluntarily recalling the affected batches
التوصيات
For healthcare professionals, Stop dispensing the above batch immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.
for patients
- Consult your healthcare provider prior to discontinuing use of the affected batch, or for any health concerns.
- Contact the recalling firm or Saudi FDA if you have any questions about the recall.
- 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).
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