الاسم التجاري | الاسم العلمي | رقم التسجيل | رقم التشغيلة المتأثرة | الشركة الصانعة |
Trade Name | Scientific Name | Register Number | Affected batch number | Manufacturer |
ROZEL 60MG INJ | DENOSUMAB | غير مسجل | 23120007 | Intas Pharma |
23120005 |
Issue :
SFDA has issued a recall of two batches of Rozel due to the product is not comply with the requirements of the executive regulations for the Pharmaceutical establishments system.
Recommendations :
For healthcare professionals:
- Stop dispensing the two batches of product immediately. Embargo/Quarantine all remaining stock. Affected batches should be returned to the supplier.
- Contact the recalling firm or SFDA if you have any questions about the recall.
- Adverse reactions or quality problems experienced with the use of this two batches may be reported to Saudi Vigilance either online or call center (Call 19999).