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Recall one batch of MYCOSAT 100,000IU\ML ORAL suspension

2023-05-24

Product Description :

 

الاسم التجاري

الاسم العلمي

رقم التسجيل

رقم التشغيلة المتأثرة

الشركة الصانعة

Trade Name

Scientific Name

Register Number

Affected batch number

Manufacturer

MYCOSAT 100,000IU\ML ORAL SUSP

Nystatin

20-290-03

OB597

Amman Pharmaceutical Industries (API)

Issue :

Saudi FDA issued Recall one batch of MYCOSAT 100,000IU\ML ORAL SUSP due to presence of black particles. Amman Pharmaceutical Industries (API) is voluntarily recalling the affected batch.

Recommendations :

For healthcare professionals, Stop dispensing the above batch immediately. Embargo/Quarantine all remaining stock. Affected batch should be returned to the supplier.

for patients

  • Consult your healthcare provider prior to discontinuing use of the affected batch, or for any health concerns.
  • 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).


Recall one batch of MYCOSAT 100,000IU\ML ORAL suspension