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

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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).
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