Recall some batches of Renis Capsule

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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

RENIS 12.5 MG CAPSULE

SUNITINIB

299-334-19

1449

1460

1461

The Arab Pharmaceutical Manufacturing PSC Sult

RENIS 25 MG CAPSULE

300-334-19

1462


Issue :

Saudi FDA issued Recall some batches of Renis Capsule due to out of specification results in microbial contamination test ( Total Viable Aerobic Count-Fungi ). Jazeera Pharmaceutical Industries (JPI) is voluntarily recalling batches.


Recommendations :

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

for patients

  • Consult your healthcare provider prior to discontinuing use of the affected batches, 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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