Notification on recall of active ingredients
Under the Health Products (Active Ingredients) Regulations 2023 (regulation 24), you are required to maintain records of reported or suspected defect in the active ingredient. These records should contain essential information on the identity of the active ingredients, detailed description of the defect, investigation of root causes, any impact assessment performed, and any corrective or preventive actions taken. Such information should be made available to the HSA inspectors as and when required.
If you decided to initiate a recall of the defective active ingredient after reviewing their investigation, the manufacturer is required under the Health Products (Active Ingredients) Regulations 2023 (regulation 25), to notify the HSA before the start of the intended recall.
Please submit the notification recall of defective active ingredients using this form: Notification of Recall for Active Ingredients
For further enquiries about recall of specific lot of active ingredients by local manufacturer, please contact HSA_gmp@hsa.gov.sg.