Incorrect Singapore-specific Instructions for Use supplied with specific batches of Restylane Lidocaine 1mL

Galderma Singapore Pte Ltd would like to inform healthcare professionals that three batches of Restylane Lidocaine 1mL may be attached with Singapore-specific Instructions for Use (IFU) for Restylane Perlane Lidocaine instead. This can result in Restylane Lidocaine mistakenly being used instead of intended Restylane Perlane Lidocaine. Based on Galderma’s assessment, the risk of patient injury is low as the Singapore-specific IFU for Restylane Lidocaine and Restylane Perlane Lidocaine are very similar in terms of Intended Use and identical in terms of Mode of Action, Warning, Precautions, Adverse Events, and Treatment Procedure. No special management of patients is required as the product is biodegradable. Please refer to the letter for details. 
Healthcare professional, Medical devices
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.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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