Recall some batches of Renis Capsule
2023-08-15Product 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).