PRODUCT RECALL

“Recall” means a firm’s removal or correction of a marketed

PRODUCT RECALL product that the Food and Drug Administration considers to be
in violation of the laws it administers and against which the
agency would initiate legal action,e.g.., seizure.

REPORTED BY: A procedure of retrieval or withdrawal of products known or

LAPIÑA, IREAL suspected to be defective, promptly and effectively, from the
APA, ROSALIE market.
LAUGLAUG, PAUL

PRODUCT RECALL 9.13 Responsibility and procedures for recall of the product shall
be established by the manufacturer to facilitate the recall of a
THE MAIN OBJECTIVE OF THIS RECALL plan are: batch from any link of the distribution chain when this becomes
Stop the distribution and sale of the affected product
necessary.
effectively notify Management, customers and regulatory
authority 9.14 - The recall procedures shall take into account the degree
Efficiently remove the affected product from the market and level of recall which in line with the NRA requirement
place, warehouse and/ or distribution areas.
Dispose and Conduct a root cause analysis and report the The procedure shall describe the degree and level of recall in
effectiveness and outcome of the recall. accordance to NRA requirement.
Implement a corrective action plan to prevent another recall
 Recalls could be initiated:
(a) By Company (Voluntary Recalls) As a result of defective Example on Classification of Recall
reports from various sources such as manufacturers, A recall will be classified depending on the potential hazard
wholesalers, retailers, medical practitioners, hospital and retail of the defective product.
pharmacists, end-users and members of the public. All recalls
triggered by the company voluntarily shall be reported to the
Class 1 Recall
NRA.
Initiated when the product defect poses a life-threatening
(b) By NRA (Mandatory Recalls) As a result of adverse drug
situation to users. Some examples of defects that will result
reaction monitoring, product quality
in Class 1 recall are contamination with toxic substances
surveillance or defective reports from reputable sources.
and products with major labelling errors.

Class 2 Recall
Class 3 Recall

It is issued when a product has defects that might cause Initiated when the problem or defect is not likely to cause any
temporary or mild health problems but are unlikely to cause harm to users. This includes minor issues like packaging
serious harm. Examples include labeling mistakes or products problems or small violations of regulations that have little to no
that don't meet quality standards but pose minimal risk to users. health risk.
 Recall to Retail level includes:
9.15 - Any action taken to recall a product suspected or known
to be defective or hazardous, shall be done immediately and in
• All pharmacies and other retail outlets (eg. health food stores,
accordance with a pre-determined plan. The procedures to be
supermarkets )
followed shall be specified in writing and made known to all
• Healthcare practitioners' establishments
that may be concerned.
• Nursing homes and other related institutions
9.16 - A person shall be designated as responsible for
• Clinical trial centres
execution and co-ordination of recalls and shall be supported
• Wholesale level
by sufficient staff to handle all the aspects of the recalls with
• Recall to Consumer level includes
the appropriate degree of urgency. This responsible person
• Patients
shall normally be independent of the sales and NRA
• Other consumers
requirements.
• Wholesale and retail levels

SOP for Recall

Identify the Issue - detect the defect or safety concern. Recall shall be handled immediately and in accordance to procedure
Assess the Risk - determine the recall class based on severity. and NRA requirement:
Notify Authorities - Inform regulatory bodies about the recall. • Must designate a person responsible for execution and co- ordination
Initiate Recall - communicate with distributors, retailers, and customers of recalls and this person shall not be from the sales/marketing
to remove the product. department and the person liaising with NRA e.g. preferable person is
Remove Product - ensure the product is taken off shelves and returned Head of Quality Unit (QA/QC) or regulatory affair personnel.
from customers. • Sufficient staff must be given to provide support (e.g. to carry out
Investigate Cause - analyze the cause of the defect to prevent investigations, to generate distribution records, to contact customer
recurrence. and consumers, to retrieve products back from the market, to securely
Dispose or Correct - safely dispose of or correct the defective product. store products in warehouse and retrieved
Report and Document - keep records and submit final reports to from market, to generate recall reports, to liaise with NRA, etc)
authorities.
In the event that a recall is deemed necessary, the company also 9.18 - Recall operation shall be capable of being initiated immediately
has to: and at any time.
1. Cease all sales of defective products immediately 9.19 - All NRA of all countries to which products may have been
2. Quarantine all defective stocks distributed shall be informed immediately if products are intended to
3. Inform all affected wholesalers / distributors / retailers to do be recalled because they are, or are suspected of being defective.
likewise first through verbal communication and followed by recall 9.20 - The distribution records shall be readily available to the
letter or when there is a risk of significant hazard to consumers and person(s) responsible for recalls, and shall contain sufficient
the distribution has been extensive, information on distributor / importer / retailer / wholesalers and
4. The Company responsible shall consider employing all possible directly supplied customers (with latest and valid addresses, contact
mass communication media available including newspaper, radio number including mobile phone, phone and/or fax numbers inside and
and television broadcast to disseminate the outside working hours, batches and amounts delivered), including
recall information to the consumers. those for exported products.

Recalled products shall be identified, recorded and stored

separately in a secure area while awaiting a decision on their fate. 9.17 - There shall be established written procedures, regularly
9.22 - The progress of the recall process shall be recorded and a checked and updated when necessary, in order to organise
final report issued, including reconciliation between the delivered any recall activity.
and recovered quantities of the products.
• There shall be designated and secured area for storage of recalled 9.23 - The effectiveness of the arrangements for recalls shall
products be evaluated regularly.
• A final report which include reconciliation of products and
destruction of recalled products, shall be established.
Regularly evaluate the initiation of recall (i.e. the procedure is
regularly checked to assess the effectiveness (how fast to
generate distribution records, generate recall report, etc) and
the procedure shall be updated if it was found ineffective.)
Product Recalls related documentation include: THANK YOU
• Sample Procedure on Product Recalls. (Refer to Annex 4)
• Product Recall Record Form. (Refer to Annex 5)