Voluntary recall of all Astrodal (Temozolomide) Capsule 20mg due to out-of-specification (OSS) event

Entrepharm Pte Ltd would like to inform healthcare professionals of a voluntary recall of all Astrodal Capsule 20mg due to an out-of-specification (OOS) event. The root cause is the setup adjustment condition of the packaging machine which led to a minor package defect. The product with this minor package defect could contribute to unspecified impurity OOS under higher humidity storage condition for a long time. Healthcare professionals will be updated on the replacement supply as soon as possible. In the interim, healthcare professionals are advised to review their patients’ treatment needs and to determine the treatment alternatives based on their clinical judgment. Please refer to the letter for details.

 
 
Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.moh.gov.sg/hpp/, and follow the procedures below to access the MOH Alert system.

Step 1: On the top navigation ribbon of webpage, select 'For Healthcare Professionals' followed by 'Health Professionals Portal' and click on the choice of profession. User will be redirected to the specific HPP webpage for the selected profession.

Step 2: Click on the Restricted Content icon on the left panel of webpage and login via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’ section

Step 4: Click on the Drug Alert tab to view the DHCPLs.