Recall all batches from the product: Rosa 10 mg Film coated Tablet

Recall all batches from the product: Rosa 10 mg Film coated Tablet

2026-06-04

Product Description :

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

Rosa 10 mg

ROSUVASTATIN

1102244897

All batches

BATTERJEE PHARMACETICAL FACTORY

Issue :

SFDA has issued a recall all batches from the product: Rosa 10 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.

Recommendations :

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).


Recall all batches from the product: Rosa 10 mg Film coated Tablet