Recall of batch 656089 from the product: BUSULCAN 6 mg/ml Vial

Recall of batch 656089 from the product: BUSULCAN 6 mg/ml Vial

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

BUSULCAN 6 mg/ml Vial

BUSULFAN

2412246484

656089

PHARMASCIENCE INC.

Issue :

SFDA has issued a recall of batch 656089 from the product: BUSULCAN 6 mg/ml Vial due to a potential risk that the impurity Mesyl-4-acetyl-butanediol (MABD) could exceed the accepted limits of the approved specifications before the end of the shelf life, potentially affecting the safety and quality of the product

Recommendations :

For healthcare professionals: Stop dispensing the batch 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 of batch 656089 from the product: BUSULCAN 6 mg/ml Vial