Health Science Authority
Home

Guidelines on Product Defect Reporting and Recall Procedures

  • Bookmark and Share
  • Print

Objective

When products are suspected of being potentially harmful to users due to their defective quality, safety or efficacy, they may be subjected to a recall and all related information must be reported to the Enforcement Branch of HSA.

The following guidelines are intended to ensure that in the event of a necessary recall, the recall operations are effectively and efficiently carried out by the product owner/licence holder, manufacturer or importer (hereinafter known as the "Company") responsible in order to safeguard public health.


Definitions

Product Defect
A suspected deficiency which may produce an impact, whether directly or indirectly, on the continuing safety, quality and efficacy of a product.

Product Recall
A permanent removal of the affected products from the market OR a temporary removal for product correction, after which the corrected products may be returned to the market for sale.

A specified timeline will be given by HSA to a Company to recall the affected product from the market.

The classification and level of recall will depend on the potential hazard of the defective product and the extent of product distribution. These are determined after consultation between the Company and HSA.


Assessment of Recall

(a) Classification of Recall

A recall will be classified as a Class 1 recall or Class 2 recall depending on the potential hazard of the defective product.

Class 1 Recall
Initiated when the product defect poses a life-threatening situation to users. Some examples of defects that will result in Class 1 recall are non-sterile injections, contamination with toxic substances and products with major labelling errors.

Class 2 Recall
Initiated when the problem or defect is unlikely to cause serious harm to users. Some examples of defects that will result in Class 2 recall include products with minor labelling errors or products which fail to meet product specification or pharmacopoeia standards but are likely to cause minimal hazard to users.

(b) Level of Recall

There are 3 levels of recall, namely: Wholesale, Retail and Consumer.
Each recall will be assigned the appropriate level of recall depending on the nature of defect, the distribution networks of the product and the extent of distribution.

Recall to Wholesale level includes 
All parties involved in wholesale sale and may include wholesalers and retail pharmacies

Recall to Retail level includes
- All restructured and private hospital pharmacies
- Retail pharmacies
- Medical, dental and other healthcare practitioners' establishments
- Nursing homes and other related institutions
- Clinical trial centres
- Other retail outlets eg. health food stores, supermarkets
- Wholesale level

Recall to Consumer level includes
- Patients
- Other consumers
- Wholesale and retail levels


Initiation of Recall

(a) Recall Initiated by Company

Recall may be initiated by the Company as a result of defective reports from various sources such as manufacturers, wholesalers, retailers, medical practitioners, hospital and retail pharmacists, end-users and members of the public.

(b) Recall Initiated by HSA

Recall may also be initiated by HSA as a result of adverse drug reaction monitoring, product quality surveillance or defective reports from reputable sources.


Responsibilities of The Company

(a) Informing HSA's Enforcement Branch 

It is the prime responsibility of the company to inform HSA's Enforcement Branch on receipt of any product defect information, regardless of whether the surfaced information may, or may not lead to a subsequent recall of the product. On receipt of such information, the company has to undertake to inform HSA's Enforcement Branch recall officer within 24 hours.

The Company is also fully responsible for recalling the defective products and notifying all customers, and if necessary, healthcare professionals and the general public, to alert them about the recall.

(b) Maintenance of Sales Records

The Company must maintain and keep proper wholesale records for each product for a minimum period of two years from the date of the last entry. All records should be readily available so as to expedite a recall when necessary.

(c) Establishment of Standard Operating Procedures (SOP) for Product Recall

The company should establish proper SOP for effective recall of product in the event that such action becomes necessary. All staff likely to be involved in a product recall should be trained in the relevant procedures and have access to a copy of the Company's SOP whenever they are required to act.

(d) Implementation of Recall

The following flowchart acts as a guide for the company when it receives product defect information.

Company receives product defect information
Company to alert Enforcement Branch recall officer using Form RR1/007 within 24 hours
Classification, Level and Strategy of recall to be finalised after discussion with HSA
In the event that a recall is deemed necessary, the company has to:
1.Cease all sales of defective products immediately
2.Quarantine all defective stocks
3.Inform all affected wholesalers / distributors / retailers to do likewise first through verbal communication and followed by recall letter (GL2/001)
Arrangement for collection of defective stocks from affected wholesalers / distributors / retailers for collation and quarantine in warehouse
1.    Complete the recall and submit full recall report using RR2/008 to HSA's Enforcement Branch recall officer within 3 weeks from the date of initiation of recall
2.    Submit proof of action taken on recalled stocks (Re-export documents or Certificate of destruction) within 3 months from the date of completion of recall
3.    Submit proposal of corrective action(s) for approval (if any)
4.    Institute corrective action(s) on approval (if any)
 
(e) Maintenance of Up-to-Date Contact Details

Contact details for the Company should be maintained up-to-date at all times.
It is the responsibility of the Company to contact HSA proactively whenever there are any changes in the contact details, such as the person responsible, telephone number, fax number, address and email address.


Contact HSA's Enforcement Branch

All enquiries or necessary information pertaining to a product defect or recall should be forwarded to:

Enforcement Branch 
Enforcement Division
Health Products Regulation Group
Health Sciences Authority

11 Biopolis Way
#11-03 Helios
Singapore 138667
Fax: 65 64789065


Recall Officers
Ms Josephine Goh 
Tel: 65 68663533
Email: GOH_hui_min@hsa.gov.sg

Mr G. Haridass
Tel: 65 68663487
Email: HARIDAS_N_GOVINDARAJAN@hsa.gov.sg

When there is a risk of significant hazard to consumers and the distribution has been extensive, the Company responsible is required to employ all possible mass communication media available including newspaper, radio and television broadcast to disseminate the recall information to the consumers.

In circumstances when a media release is required, companies are to consult HSA prior to release of any recall information.


Conclusion

Companies are responsible for the quality, safety and efficacy of their products. All efforts must be made to ensure that recall operations are carried out as efficiently and effectively as possible. Appropriate follow-up actions must also be taken to prevent future recurrence of similar problems.


Last updated on 07 Aug 2013 19:10:53
Best viewed using Internet Explorer 7.0 and above. | Privacy Statement | Terms of Use | HSA Data Protection Policy | Rate Our Website
Health Sciences Authority © 2007-2011. All Rights Reserved.