Precautionary Recall of certain batches of Navelbine Injection (Vinorelbine Ditartrate) 10 mg/mL

Orient Europharma Pte Ltd, in consultation with HSA is conducting a voluntary recall of 3 batches of the antineoplastic agent, Navelbine® injection 10mg/mL (SIN06778P) due to an atypical trend in the degradation profile resulting in an increase of impurity S/D6 observed in these batches. The affected batches are P505, P506 and P507. The content of impurity is still consistent with the current registered specifications to product expiry. The increase in impurity is not expected to impact the efficacy of Navelbine® Injection nor increase risk to patients. The recall is a precautionary measure and all healthcare professionals are advised to stop using the affected batches.

 
 
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.