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沙特阿拉伯王国政府所属的官方政府网站。
icon 周四 13 八月 2026
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沙特官方政府网站的域名以下列后缀结尾 gov.sa

沙特阿拉伯王国所有政府机构的官方网站均以 .gov.sa 结尾。

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在数字政府管理局注册,编号:

20250831619
建议

Recall all batches from the product: Rosa 20 mg Film coated Tablet

القسم

Drugs

violet
drugs

Recall all batches from the product: Rosa 20 mg Film coated Tablet

icon 2026-07-02
الاسم التجاري الاسم العلمي رقم التسجيل رقم التشغيلة المتأثرة الشركة الصانعة Trade Name Scientific Name Register Number Affected batch number Manufacturer Rosa 20 mg ROSUVASTATIN 0802244890 All batches BATTERJEE PHARMACETICAL FACTORY
التصنيف
ملف
التاريخ
2026-06-04
اسم المستحضر
Rosa 20 mg
اجراء الاستدعاء
مستوى الاستدعاء
نوع المستحضر
سبب السحب

SFDA has issued a recall all batches from the product: Rosa 20 mg Film coated Tablet due to Non-compliance of the active pharmaceutical ingredient (API) manufacturer CADCHEM LABORATORIES LIMITED with Good Manufacturing Practice (GMP) requirements, which may affect the safety and quality of the product.

التوصيات

For healthcare professionals: Stop dispensing the product immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.
For patients,
1.    Consult your healthcare provider prior to discontinuing use of the affected batch, or for any health concerns.
2.    Contact the recalling firm or SFDA if you have any questions about the recall.
3.    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).