Product defect reporting and recall procedures

Find out when and how to report and recall defective products that may potentially cause harm to patients or to the public health.

Overview

Any product defect that affects the safety, quality and efficacy of the product, and may cause potential harm to the patient or public health, must be reported to us.

Product registrants, manufacturers, importers and suppliers are responsible for the safety, quality and efficacy of their therapeutic products, and should have systems and procedures in place to investigate, review and report the product defects to us, and if necessary, to promptly recall affected products.

All therapeutic product defects and recalls will need to follow classifications and timelines.

Product defect reporting and recall requirements

Report product defects

When to report

A defective therapeutic product that has to be reported is one that:

  • Has or has possibly been adulterated or tampered with.
  • Is or is possibly an unwholesome health product.
  • Is or is possibly of inadequate quality or unsafe or inefficacious for its intended purpose. 

Classification of defect

A defect is classified into either critical defect or non-critical defect according to the potential impact to public health and the risks posed to the intended user of the therapeutic product.

Critical defect

A critical defect is as one that can pose a serious threat to the intended users or public health in Singapore. A serious threat means a hazard that occurs in association with the use or administration of a therapeutic product and that may lead to the death of, or a serious injury to, any person.

Non-critical defect

A non-critical defect is one which does not meet the criteria of “critical defect” but may cause illness or affect the outcome of a person’s medical treatment and/or significantly affect the quality of a therapeutic product.

Product defect classification

Reporting timelines

Product defect classification When to report
Critical defects Within 48 hours (excluding Sundays and public holidays)
Non-critical defects Within 15 calendar days

Note: For critical defects that pose a safety risk to the public, prompt measures must be taken to minimise the risk (including market actions) even if they need to be taken during non-working hours.

What to report

Critical or non-critical defects of therapeutic products affecting:

  • Batches which have been imported for supply or supplied in Singapore.
  • Batches which have not been supplied in Singapore but where the company is aware that the root cause of the defect could potentially affect the local or future importation.

In general, we will require you to submit an investigation report for product defects, and the report should include the following details:

  • Description of the defect
  • Determination of the extent of the defect
  • Test results of the defective product, if available
  • Information on whether other similar defects had occurred locally or globally
  • Identification of the potential root cause(s) of the defect
  • Assessment of the short-term and long-term risk(s) posed by the defect
  • Recommendation and/or decision on risk mitigation actions to be taken such as batch or product recall or other market actions
  • Description of the Corrective and Preventive Actions (CAPAs) taken or to be taken

How to report a defect

You may complete the Product Defect Reporting Form and submit it to us.

What happens after a defect is reported

Upon receipt of the product defect report, we will review the information provided in the report and may request that you provide further information required for our assessment.

Depending on the potential risk to the intended users or to public health, we may require additional risk control measures, such as:

  • A product recall.
  • Issuance of Dear Healthcare Professional Letter.
  • Issuance of a press release.

We may also suspend or cancel the product registration if there are critical and/or major defects which have not been addressed. This will be assessed on a case by case basis.

Refer to our Guide for Industry- Reporting of Therapeutic Product Defects and Recall of Therapeutic Products for more information on product defect reporting.

Recall products

When to initiate a product recall

When a defective therapeutic product is considered to present a risk to the intended user or public health, we may require you to remove it from the market by recalling the affected batches or, in extreme cases, recalling all batches of the product.

You may also initiate a recall of a therapeutic product even if:

  • The defect does not pose a risk to the intended user and public health.
  • Other reasons, such as for commercial purposes.

Product recall classification

The classification of a product recall will depend on the severity of the defect and its impact on a person's health.

Class 1 recall

A Class 1 recall involves the use of, or exposure to, a therapeutic product with a critical defect that may reasonably lead to serious adverse health consequences or death.

Class 2 recall

A Class 2 recall involves the use of, or exposure to, a therapeutic product with a non-critical defect that results in either one of the following scenarios:

  • Temporary or medically reversible adverse health consequences.
  • Remote probability of serious adverse health consequences.

When to report

You must notify us within 24 hours (excluding Sundays and public holidays) before the start of the intended recall. We will require you to:

  • Investigate the matter leading to the recall of the therapeutic product and provide a report of the findings of the investigation.
  • Take measures we think are necessary. This includes, but is not limited to, an escalation of the class or level of product recall so as to safeguard public health and safety.

Recall timelines

Recall steps Class 1 recall Class 2 recall
Notify HSA Within 24 hours (excluding Sundays and public holidays) Within 24 hours (excluding Sundays and public holidays)
Issue Dear Purchaser Letter Within 24 hours (excluding Sundays and public holidays) of recall commencement Within 3 days (excluding Sundays and public holidays) of recall commencement
Complete recall process Within 1 week Within 3 weeks

Level of recall

The level of product recall describes the action required based on the extent of distribution of the affected product and potential hazard to public health.

Consumer level

  • Usually initiated when the risk to patients or consumers is assessed to be unacceptable, and where the product has been supplied to consumers.
  • Affected product or batches are to be recalled from all wholesale and retail distributors as well as patients or consumers who had been supplied with the affected batches.
  • The recalled product or batches should be segregated in a secured area before the implementation of follow-up actions, e.g. destruction of the products.
  • All wholesale and retail supply of the affected product or batches should be suspended.

Retail level

  • Usually initiated when the risk to patients or consumers is assessed to be moderate to high but recall at consumer level is not deemed necessary (e.g. if the product is administered by healthcare professionals and not directly supplied to patients).
  • All wholesale and retail supply of the affected product or batches should be suspended.
  • Affected product or batches are to be recalled from all wholesale and retail distributors including:
    • Restructured and private hospital pharmacies.
    • Retail pharmacies.
    • Medical, dental and other healthcare practitioners' establishments.
    • Community hospitals, nursing homes and other related institutions.
    • Other retail outlets, such as health food stores and supermarkets.
  • The recalled product or batches should be segregated in a secured area before the implementation of follow-up actions, e.g. destruction of the products.

Wholesale level

  • Usually initiated when the risk to patients or consumers is assessed to be low or where other measures can be taken to mitigate the risk to prevent disruption in supply of critical therapeutic products, such as visual inspections or other interventions by healthcare professionals before supply to patients.
  • All wholesale supply of the affected product or batches should be suspended.
  • Affected product or batches are to be recalled from all wholesalers.
  • The recalled product or batches should be segregated in a secured area before the implementation of follow-up actions, e.g. destruction of the products.

Product recall requirements

Product recall stages Details
Initiate recall You may initiate a product recall as a result of reports of product defects from healthcare professionals and the public.

You do not need to seek approval from us for initiating a product recall, but you must notify us of the intended recall within 24 hours (excluding Sundays and public holidays) before the start of the intended recall.
Follow recall process and procedures The requirements for management of recall, including the types of records that should be kept for supply chain traceability, as well as sales and distribution records of wholesale or retail supply, are stated in the Good Distribution Practice standards.
Notify stakeholders of recall actions You should communicate the presence of defects and the recall actions taken through a Dear Purchaser Letter, which should include the following:
  1. Audience or targeted recipient.
  2. Purpose of letter (with product identification, class and level of recall).
  3. Description of problem and potential health hazards.
  4. Instruction to customers.
  5. Company's contact.

You do not need to seek our approval to issue a Dear Purchaser Letter, but you will need to send us a copy of the Dear Purchaser Letter for reference and documentation purposes.

A Dear Healthcare Professional Letter may be required to alert doctors, dentists pharmacists, and/or relevant healthcare professionals about important information regarding safety, quality and efficacy concerns related to the use of a defective product that presents potential risks to patients and/or public health.

Issue press release You may be required to issue a press release to update the public on the recall of widely distributed products in a timely manner.
Complete recall You must inform us on the completion of a product recall through the Online Product Recall Completion Form. As part of the recall completion report, companies should update us of the follow-up actions that will be taken for the recalled products. Such actions include, but are not limited to the following:
  • Destruction of the recalled products. You should submit the certificate of destruction to us within 3 months from the completion of the recall. Prior approval for destruction is not required.
  • Re-introduction of the recalled products into the market after appropriate CAPA has been implemented. You are required to seek and obtain approval from us before the re-introduction of the products. Recalled products can only be re-introduced if:
    • Appropriate CAPA has been implemented.
    • The products are in good condition.
    • It is known that the products have been transported, stored and handled under proper conditions.
    • The remaining shelf life period is acceptable.
    • The products have been examined and assessed by appropriate and qualified personnel, taking into account the nature of the product, any special storage conditions required, and the time which had elapsed since it was distributed.
If any other actions are to be taken, specify them on the Online Product Recall Completion Form and they will be subjected to our approval.

How to initiate a recall

You may complete the Online Product Recall Completion Form and submit to us.

Refer to our Guide for Industry- Reporting of Therapeutic Product Defects and Recall of Therapeutic Products for more information on recall procedures.

Video guide

Watch our video guide on product defect and recall reporting and management for therapeutic products in Singapore. 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.

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