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.

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

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.