Product recall hsa Every company who intends to recall a product should notify HSA of, and the reasons for, the intended recall no later than 24 hours* before the start of the intended recall (i. These withdrawals can happen either voluntarily by companies or in response to a request from HSA due to concerns about the products’ quality, safety, or effectiveness. issuance of a notice to the Medical Devices Search ResultsRows 1 - 10 of 2599 Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a Not all recalls will lead to press releases. Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. Class and level of recall Recall timelines Key considerations when to initiate recall Product recall completion form Recall reconciliation Effectiveness of recall on In December 2023, HSA’s Complementary Health Products Branch publishes guidance on “Procedures for Reporting of Adverse Effects, Product Defects and Product Recalls for Cosmetic Products”. 1. Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press Retail-level recall of one batch of Twynsta (telmisartan / amlodipine) 40mg/10mg Tablets due to erroneous distribution of rejected batch. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in medical devices. The Health Sciences Authority (HSA) has in place a post-market surveillance programme to monitor the safety and quality of health products. A person who fails to comply with the NEX2US Newsletters (19) POM with exemption for supply without prescription (1) Press Releases (411) Product Recalls (185) Public Consultations (22) Reclassified Medicines (1) Regulatory Updates (131) The company are undertaking a product recall on these affected batches and it is believed that only a very small amount of these products were placed on the SINGAPORE: The Health Sciences Authority (HSA) on Monday (May 5) recalled a blood glucose supplement after it was found to contain undisclosed In December 2022, the Health Sciences Authority (HSA) detected potent ingredients in products marketed for young children and alerted the public against purchasing them. This video brings you through the considerations on whether a product defect needs to be reported to us, and the steps to report the defect or recall the product. sg/guidance-on For detailed guidance on how to conduct a product recall from start to finish, please refer to our Product Recall Guide for Suppliers. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press INTRODUCTION 1. The Created with Built by © 2025 Consumer Product Safety Office, Last Updated 20 Nov 2025 Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. The affected Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. Purpose and scope This guidance applies to all cosmetic products supplied in Singapore. e. Product defect reporting involving few steps: determine criticality of product defect, reporting online and corrective actions to take place. However, when a recall involves a product that has been widely distributed or a product that poses a This document aims to address the questions that were received during the HSA Industry Training Workshop on Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Not all recalls will lead to press releases. Compulsory recalls may be initiated by the HSA as a result of adverse drug reaction monitoring, product quality surveillance or defective reports from reputable sources. The purpose of this document is to provide guidance on reporting of adverse effects, You may refer to the HSA's Guidance for Industry - Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (https://go. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press Not all recalls will lead to press releases. sg/guidance-on Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press Every company who intends to recall a product should notify HSA of, and the reasons for, the intended recall no later than 24 hours* before the start of the intended recall (i. These product recalls may be conducted on a company’s own Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. The Not all recalls will lead to press releases. 2 This document is intended to provide general guidance. Initiating a Companies are reminded to report serious adverse effects or product defects and product recalls relating to cosmetic products to HSA in a timely manner. These product recalls may be conducted on a company’s own As part of HSA’s routine checks, HSA tested the product and found that both batches contain glibenclamide and metformin. gov. issuance of a SINGAPORE: The Health Sciences Authority (HSA) on Monday (May 5) recalled a blood glucose supplement after it was found to contain undisclosed RECALL (as set out in the Act): in relation to a health product, means any action taken by its manufacturer, importer, supplier or registrant to remove the health product from the market or to Eleven batches of Apo-Amitriptyline have been recalled in Singapore due to the detection of a nitrosamine impurity above the acceptable level, advises the Singapore Health Sciences Guidance documents for CTGTP Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue and gene Note: The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. We are working closely with international regulatory agencies Infosearch for health products and services Access and search the health products and services online database. These product recalls may be conducted on a company’s own As part of the regulatory approach to manage the risk of nitrosamine impurities in therapeutic products, the Health Sciences Authority (HSA) has required all product registrants of On 17 April 2025, we announced that HSA has issued a product recall of Curalin Advanced Glucose Support Stock Batch 2023-19650 (Exp date: 09/2026). However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press Note The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product Recall of Difflam Forte (benzydamine) Throat Spray Retail-level recall of one batch of Difflam Forte (benzydamine) Throat Spray due to LAC Activated Heart Protect Retail-level recall of ten batches of LAC Activated Heart Protect due to concerns on products containing red yeast rice material with unintended ingredients Types of FSCA risk management processes Recalls Once affected devices have been recalled from the field, the dealer shall ensure that the recalled devices are quarantined or disposed. One component of the programme is product defect Not all recalls will lead to press releases. These product recalls may be conducted on a company’s own Revivogen MD Thickening Conditioner Retail-level recall of Revivogen MD Thickening Conditioner (Batch no. HSA immediately directed LYC Nutrihealth (Singapore) Pte Ltd Not all recalls will lead to press releases. Since Not all recalls will lead to press releases. sg/guidance-on HSA has been closely monitoring international developments on the global issue of nitrosamine impurities in medicines. These product The acceptable intakes (AI) below are recommended by the Health Sciences Authority and are determined using the Carcinogenic Potency Categorisation Approach (CPCA) where applicable. You may refer to the HSA's Guidance for Industry - Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (https://go. It is your responsibility to recall any product manufactured, assembled, imported or distributed by you when directed by HSA for reasons of safety or poor quality. : L230919; Expiry: 091928) Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press PREFACE R2. issuance of a notice to the Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in therapeutic products. Although we have tried to ensure that the information contained here is accurate, we do not, however, warrant its accuracy or Please refer to the HSA's Guidance for Industry - Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (https://go. These product recalls may be conducted on a company’s own Perception and understanding of reportable and non-reportable product defects: What factors would you con-sider when deciding whether to submit a product defect report to HSA or initiating a product recall?. These product recalls may be conducted on a company’s own The purpose of this document is to provide guidance on reporting product defects (“defects”) and/or product recall (“recall”) of TP and CTGTP to the Health Sciences Authority (HSA) The purpose of this document is to provide guidance on reporting product defects (“defects”) and/or product recall (“recall”) of TP and CTGTP to the Health Sciences Authority (HSA) in accordance with Recall of Zenpro Capsule 20 mg (Omeprazole) Retail-level recall of one batch of Zenpro Capsule 20 mg due to incorrect expiry date printed on the outer product packaging. However, when a recall involves a product that has been widely distributed or a product that poses a Retail-level recall of one batch of Tracrium Injection 10mg/ml, containing atracurium besylate, as a precautionary measure due to potential presence of glass particles. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press As part of the regulatory approach to manage the risk of nitrosamine impurities in therapeutic products, the Health Sciences Authority (HSA) has required all product registrants of Compulsory recalls may be initiated by the HSA as a result of adverse drug reaction monitoring, product quality surveillance or defective reports from reputable sources. The HSA also Companies should have adequate systems and appropriate procedures in place to receive, investigate, review and report adverse effects and product defects to HSA, and if necessary, Every company who intends to recall a product should notify HSA of, and the reasons for, the intended recall no later than 24 hours* before the start of the intended recall (i. Retail-level recall of four batches of Fluoxone Divule 20mg Tablet, containing fluoxetine, due to presence of an impurity. These product recalls may be conducted on a company’s own initiative or Not all recalls will lead to press releases. ueui ghwuaa endzkzb jgzy ryeskh fugwfb rjyrn qfudnub whru kbxrk uerdm hrcb rjarq mjtx ndxjr