13 December 2017
Withdrawal Of Two Batches Of The Drug Jusprin 81Mg Batch. 0540 & 0541 Manufactured By Julphar
Reference: CIR-2017-SHN0795
To: All Health Facilities - Private Sector in Dubai
In accordance with the recommendations of the Ministry of Health and Prevention (MOH&P) and interest to maintain community and public health safety, we would like to draw your attention that the MOH&P has withdrawn the two batches mentioned above. The results of the tests conducted by the laboratory of quality control and research of the medical and health products of the ministry showed that they do not comply with international standards due to incomplete bio availability of the tablets after the dissolving period. The batch number and expiry dates are noted below:
Medicine Name
|
Batch No.
|
Expiry Date
|
JUSPRIN 81mg
Enteric Coated Tablet
|
0540
|
06/2020
|
0541
|
07/2020
|
Note: that the medicine is registered in the Department of Medicine in the MOHP has decided the following:
§ The authorized agent must withdraw the two batches mentioned above from the UAE market and replace them with the correctones.
§ To avoid any violations or penalties all health facilities must adhere to this Circular in accordance with the instructions in this regard and should not use the mentioned Lot/Batch Number if available.
§ To report Adverse Drug Reaction (ADR) or Event, kindly fill out the ADR form available at the website:
http://www.cpd-pharma.ae
OR contact the following addresses:
Tel: 04-2301448 or fax 04-2301947 or
Email address: pv@moh.gov.ae
§ For more information, kindly contact the support office in Health Regulation Department on :
Telephone: 045022901-/ 5022996
Emailaddress: regulation@dha.gov.ae
Your co-operation is highly appreciated
For fully access on the circular # 125, please refer to the following link:
https://www.dha.gov.ae/Documents/%D8%AA%D8%B9%D9%85%D9%8A%D9%85%20%D8%B1%D9%82%D9%85%20125%20%D8%A8%D8%B4%D8%A3%D9%86%20%D8%B3%D8%AD%D8%A8%20%D8%AA%D8%B4%D8%BA%D9%8A%D9%84%D8%AA%D9%8A%D9%86%20%D9%85%D9%86%20%D9%85%D8%B3%D8%AA%D8%AD%D8%B6%D8%B1%20%D8%AF%D9%88%D8%A7%D8%A6%D9%8A.pdf