سحب تشغيلتين من مستحضر GONAPEPTYL Depot 3.75mg
2023-04-16وصف المنتج :
الاسم التجاري |
الاسم العلمي |
رقم التسجيل |
رقم التشغيلة المتأثرة |
الشركة الصانعة |
Trade Name |
Scientific Name |
Register Number |
Affected batch number |
Manufacturer |
GONAPEPTYL Depot 3.75mg |
Gonadotropin |
غير مسجل |
U11271F |
Ferring Pharmaceuticals Limited. |
U11571E |
سبب السحب :
Saudi FDA has issued a recall of two batches of GONAPEPTYL Depot 3.75mg due to slightly damaged sterile needle blisters were detected. As the sealing appears incomplete, a tiny breach is observed at the peel-away opening of the needle blister, potentially compromising the sterility of the needle. FERRING is voluntarily recalling the affected batches.
التوصيات :
For healthcare professionals:
- Stop dispensing the above batches immediately. Embargo/Quarantine all remaining stock. Affected batches should be returned to the supplier.
- 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).