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Recall some batches of Renis Capsule

2023-08-15

Product Description :

 

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).


Recall some batches of Renis Capsule