PHARMACEUTICAL PRODUCTS

RECALL GUIDELINES
March 2022

Licensing and Compliance Division of Drug Office,

Department of Health
Hong Kong SAR, China
Room 2001-2002, 20/F, Dah Sing Financial Centre,
248 Queen’s Road East, Wan Chai, Hong Kong
Telephone (852) 3107 3498
Facsimile (852) 3107 0221
E-mail [email protected]
Website www.drugoffice.gov.hk
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Pharmaceutical Products Recall Guidelines- 2022 Version
CONTENTS

Page
A. Introduction and Definitions 2
B. Stages of Recall Procedure 4
C. Notification of a Pharmaceutical Product Problem 5
D. Initiation of a Recall/ Information Required for Assessment of 6
Recall
E. Assessment of Recall 7
- Recall strategy
- Classification of recall
- Level of recall
F. Communication to Public 10
- Recall letters
- Press releases
G. Responsibilities of Licensee 11
- Records
- Recall procedure
- Problem reporting
- Recall
- Refund mechanism
- Post-recall
H. Evaluation of the Recall 15
I. Reinstatement of Supply 16

Appendices
One Pharmaceutical Product Problem Report Form/ Recall 17
Notification Form
Two Recall Reply Form 21
Three Final Report Form 23
Four Documents Relating to Submission of Analytical Report 25

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A. INTRODUCTION AND DEFINITIONS

Introduction

When pharmaceutical 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 report to the Drug Office, Department of Health,
HKSAR.

The Pharmaceutical Products Recall Guidelines (the ‘Guidelines’) intended to ensure

that in the event of a necessary recall, the recall operations are effectively and
efficiently carried out by the manufacturer, importer, distributor or certificate holder of
pharmaceutical product (hereafter known as the ‘Licensee’) in order to safeguard
public health.

Regulation 28(8) & 33(5) of the Pharmacy and Poisons Regulations require a holder
of a wholesale dealer licence and a manufacturer to set up and maintain a system of
control that will enable the rapid and, so far as practicable, complete recall of any lot
or batch of a pharmaceutical substance or product from sale to the public in the event
of the pharmaceutical substance or product being found to be dangerous or injurious
to health. It is mandatory that all licensees comply with Pharmacy and Poisons
Ordinance and associated Regulations. Any person who is guilty of an offence under
the above provisions of regulation is liable on conviction to a fine of $100,000 and to
imprisonment for 2 years.

The Guidelines represent Department of Health current stance on this topic. They are
recognized by the licensing authority as being appropriate to the specialized
requirements for the recall of pharmaceutical products and are the licensing condition
for all licences issued by the licensing authority. Any licensee has failed to comply with
the conditions or has been convicted of an offence under the Ordinance/ Regulations,
the licensing authority may revoke or suspend the licence for a period as it thinks fit.

The role of the Drug Office of the Department of Health in a recall is to assess the
adequacy of the Licensee’s decision on the recall of the product and to monitor the
progress and effectiveness of the recall. The Drug Office may alert the public of the
product problem and instruct the Licensee to recall and dispose of the product
according to the circumstances.

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Definitions

Licensee-
Licensee is the person or business that has the primary responsibility for the supply.
The Licensee could be the manufacturer, importer, distributor or the certificate holder
of a pharmaceutical product.

Pharmaceutical product-
Under the Pharmacy and Poisons Ordinance, pharmaceutical product
(a) means a substance, or combination of substances that –
(i) is presented as having properties for treating or preventing disease in
human beings or animals; or
(ii) may be used in or administered to human beings or animals with a view
to -
(A) restoring, correcting or modifying physiological functions by exerting
a pharmacological, immunological or metabolic action; or
(B) making a medical diagnosis; and
(b) includes an advanced therapy product*.

Recall-
A process for withdrawing or removing a pharmaceutical product from the
pharmaceutical distribution chain because of defects in the product, complaints of
serious adverse reactions to the product and/ or concerns that the product is or may
be counterfeit. The recall might be initiated by the manufacturer, wholesale dealer
licence holder, or Department of Health.

___________________________

* “advanced therapy product”

means any of the following products that is for human use─
(a) a gene therapy product;
(b) a somatic cell therapy product;
(c) a tissue engineered product.
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B. STAGES OF RECALL PROCEDURE

The procedure is divided into six stages, which are set out below, with a reference to
the Section in which detailed information is given.

See
Recall Stage
Section
1. Receipt of Pharmaceutical Product Problem Report C
Notification to the Department of Health
Information on problem of pharmaceutical products, see also Pharmaceutical
Product Problem Report Form (Part 1) at Appendix ONE.

2. Initiation of a Recall D
Information Required for Assessment of Recall
Information on product, problem and distribution is required, see also- Recall
Notification Form (Part 2) at Appendix ONE.

3. Assessment of Recall E
The classification, level and strategy of recall are determined depending on
the potential hazard of the defective product and the extent of product
distribution.

4. Recall F
Letters and press release (if required) are dispatched to relevant firms for
notifying on the recall. See Recall Reply Form at Appendix TWO.

5. Progress of Recall and Report G

Progress reports and final report are submitted to the Drug Office. See Final
Report Form at Appendix THREE.

6. Evaluation of the Recall H

The effectiveness of the recall is monitored by the Drug Office.

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C. NOTIFICATION OF A PHARMACEUTICAL PRODUCT PROBLEM

Recall might be initiated as a result of reports or complaints on quality, safety or

efficacy on a pharmaceutical product referred to the Licensee from a variety of
sources. The reports or complaints may be referred by manufacturers, wholesalers,
retailers and hospital pharmacies, research institutes, medical practitioners, dentists
and patients, recall might also be initiated as a result of analysis and testing of
samples of pharmaceutical products by the manufacturers and by the Department of
Health. Recall of pharmaceutical products manufactured overseas might be initiated
by the local or overseas health authorities, or from information received directly from
such authorities.

Certain information is essential to permit the assessment of the validity of the report of
quality defects, safety or efficacy problem with pharmaceutical products, the potential
danger to consumers and the action appropriate to the situation. A Pharmaceutical
Product Problem Report Form (Part 1) is used to report problems to the Department of
Health, it is provided at Appendix ONE.

Serious problems which may lead to recall of Class I or Class II (refer to recall
classification at Section E) must be reported to the Department of Health within 24
hours after receipt of the complaint or report for investigation. The Pharmaceutical
Product Problem Report Form (Part 1) at Appendix ONE together with opinions on
toxicological or therapeutic hazards and the action proposed by the authorities/
organization (if any) should be referred on to the Senior Pharmacist (LC-W) of the
Department of Health. For less serious problems would result in a Class III recall, the
Pharmaceutical Product Problem Report Form should be sent to Department of
Health no later than 72 hours after receipt of complaint or report of a problem.

It should be noted that the Licensee has to send the Pharmaceutical Product Problem
Report Form (Part 1) to Department of Health prior to their decision on recall.

When the need for recall has been established, additional information is required so
that an appropriate recall strategy may be devised. A summary of the information
required is provided in Section D.

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D. INITIATION OF RECALL/ INFORMATION REQUIRED FOR ASSESSMENT OF
RECALL

When the Licensee decides to initiate a recall on a pharmaceutical product, it is

required to notify the recall situations with the Recall Notification Form (Part 2) at
Appendix ONE including information outlined below to the Department of Health
immediately after the decision to recall is made and the Senior Pharmacist (LC-W),
Department of Health is notified (refer notes of Appendix ONE on the contact
information of Senior Pharmacist (LC-W)). The Licensee shall not wait to submit this
information until ALL applicable information is prepared and assembled prior to
notification to the Department of Health. This “early” notification is necessary to allow
the Department of Health to review and comment on the written notification and to
offer guidance and assistance in the recall process.

The information required may include:

Details of the Problem

- name, telephone and facsimile number of the person reporting the problem;
- date of report;
- physical location of the problem;
- nature of the problem;
- number of similar report received;
- results of tests and other investigations on suspect or other samples.

Details of the Product

- name of the product and description including active ingredients, dosage from, strength,
registration no, pack size or type;
- batch number(s) and expiry date;
- manufacturer/ distributors and contact telephone, facsimile numbers and email address;
- date manufactured, date released or imported to Hong Kong;
- quantity of the batch, date and amount manufactured, released or imported to Hong Kong;
- local distribution list;
- oversea distribution list of product exported from Hong Kong;
- whether the product is meant to be sterile.

Health hazard evaluation and proposed action

- type of hazard, and evaluation of health hazard to user;
- action proposed by the Licensee;
- proposed recall classification and level; and
- availability of alternative product.

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E. ASSESSMENT OF RECALL

Recall Strategy
Each recall is a unique exercise. There are a number of factors common to all recalls
that need to be considered in tailoring an appropriate recall strategy. These include
the nature of the deficiency in the product, the incidence of complaints, public safety,
distribution networks, recovery procedures, resources for corrective action and
availability of alternative products.

In determining the recall strategy, the Licensee should consider the factors which may
affect the duration of the recall action and should inform the Department of Health.
The recall should be completed by the date as directed by the Department of Health.

When the required information (Section D) is available, the appropriate strategy

should be proposed by the Licensee to Department of Health. The proposed recall
strategy should be agreed by the Department of Health before implementation. The
actual implementation of the recall includes use of the basic steps which are
summarized in Section B and these will be common to all strategies.

In the recall strategy, the Licensee should mention the followings:

- Indicate the proposed level in the distribution chain to which the recall is extending
(see level of recall below), if the recall only extends to the wholesale level, the
rationale of not recalling to retail level should be explained;
- In case of consumer level recall, additional information should be mentioned-
 Indicate the location of recall spots for consumers (preferably not less then 10 recall
spots covering different district in Hong Kong), their operation time and duration (at
least 7 days);
 Indicate the hotlines number(s) for enquiry and the corresponding operating hours;
 Indicate the proposed refund mechanism at the recall spots, the conditions of refund
(applicable to opened products, expired products or parallel-imported products) and
methods of refund (by means of money, credit notes or product replacement etc.);
- Indicate the method of notification (e.g. mail, phone, facsimile, email);
- Indicate how the message of recall will be delivered to customers e.g. press
release or recall letters etc;
- If the Licensee has a website, it should consider posting the recall notification on it
as an additional method of recall notification;
- Report on what have the customers been instructed to do with the recalled
product;
- It is necessary for recalling firms to know the name and title of the recall contact
person for each of its consignees. Addressing a recall letter to a recall contact
person will expedite the recall process and reduce the potential for the recall letter

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 to get misdirected;
- If product is to be returned, explain the mechanics of the process;
- Explain if the recall will create a market shortage that will impact on the consumer;
- Determine and provide the course of action for out-of-business distributors;
- Provide a proposed disposal plan of the recalled products, whether they would be
destroyed, reconditioned or returned to overseas manufacturer; and
- Inform Department of Health before product destruction, the proposed method of
destruction would be reviewed and Department of Health may choose to witness
the destruction.

Classification
Recalls are classified according to the following system:

Class I recalls occur when products are potentially life-threatening or could cause a
serious risk to health.
Examples of Class I Defects
- Wrong Product (label and contents are different products)
- Correct product but wrong strength, with serous medical consequences
- Microbial contamination of sterile injection or ophthalmic product
- Chemical contamination with serious medical consequences
- Mix up of some products (‘rogues’) with more than one container involved
- Wrong active ingredient in a multi-component product with serious medical
consequences

Class II recalls occur when product defects could cause illness or mistreatment, but
are not Class I.
Examples of Class II Defects
- Mislabeling e.g. wrong or missing text or figures
- Missing or incorrect information- leaflets or inserts
- Microbial contamination of non-injectable, non-ophthalmic sterile product with medical
consequences
- Chemical/ physical contamination (significant impurities, cross contamination,
particulates)
- Mix up of products in containers (“rogues”)
- Non-compliance with specification (e.g. assay, stability, fill/ weight or dissolution)
- Insecure closure with serious medical consequences (e.g. cytotoxics, child resistant
containers, potent products)

Class III recalls occur when product defects may not pose a significant hazard to
health, but withdraw may be initiated for other reasons.
Examples of Class III Defects
- Faulty packaging e.g. wrong or missing batch number or expiry date
- Faulty closure
- Contamination- microbial spoilage, dirt or detritus, particulate matter

Class I or Class II recalls are considered to be urgent safety-related recalls. They

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must be reported to the Department of Health for further evaluation and investigation.

Class III recalls are considered to be non safety-related recalls.

Note: Each recall is a unique exercise and there may be occasions when the scope of
a recall can be narrowed to particular customer groups. The classification is
determined by the Department of Health. Expert advice might be sought where the
nature of the hazard or its significant is not clear.

The Guidelines do not apply to the recall of pharmaceutical products related to

regulatory issues (e.g. approved change of agent, labeling, package insert or other
registered particulars). The Licensee should follow the instruction as provided by the
Drug Evaluation and Import/Export Control Division of Department of Health and take
reference from the Guidelines.

Level
As with classification, the level (or depth) of a recall is to be assigned by Department
of Health. In determining the recall level, the principal factors to be considered are the
significance of the hazard (if any), the channels by which the pharmaceutical products
have been distributed, and the level to which distribution has taken place. Again,
expert opinion may be necessary to determine the significance of the hazard.

There are three levels of recall: wholesale, retail and consumer.

Wholesale level includes:

- All parties involved in wholesale distribution and may include wholesalers and
retail pharmacies.

Retail level includes:

- All public and private hospital pharmacies;
- Retail pharmacies;
- Clinical investigators and the institutions in which clinical investigations are
performed;
- Medical, dental and other health care practitioners;
- Nursing homes and other related institutions;
- Other retail outlets e.g. medicine shops, supermarkets and health food stores; and
- Wholesale level.

Consumer level includes:

- Patients and other consumers; and
- Wholesale and retail levels.

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F. COMMUNICATION TO PUBLIC

Recall letters
In case of a recall, the Licensee may prepare letters with a factual statement of the
reasons for the recall of the product, together with specific details that will allow the
product to be easily identified. The letter may be sent by mail, facsimile or e-mail to
the clients.

The recall letter should use company letterhead; include date and name and title of
signatory. The text of recall letter may include:
a. Description of the pharmaceutical product: name of the product; Hong
Kong registration number; name of manufacturer, pack size; dosage form;
batch number(s) and expiry date;
b. Hazard associated with the product: The reason for the recall should be
concisely explained. It should be made clear that further distribution or use of
the product should cease immediately.
c. Instruction for recall of the product: The method of return, disposal or
correction and refund mechanism of the product. There should be a request for
a response to confirm receipt and understanding of the action to be taken e.g.
pre-addressed cards, telephone replies or a form to complete and return by
facsimile or e-mail. The Licensee should clearly identify a hotline for enquiry.

For retail level recall, the Licensee should have confirmation for returning all the stock
on hand from the consignees using the Recall Reply Form at Appendix TWO.

If safety to the public is involved and distribution is limited, the Licensee may contact
the clients of the information listed above by telephone and followed by a recall letter.

Press Release
Rapid alert to public is usually reserved for hazards classified as Class I, and where
appropriate Class II, or situation where other means for controlling the hazard appear
inadequate. Rapid alert to public may be issued through appropriate channels which
may include press release.

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G. RESPONSIBILITIES OF LICENSEES

Licensee has responsibilities in relation to recall of pharmaceutical products in two

general areas:

a. in maintaining records and establishing procedures which will assist in

facilitating recall should such action become necessary; and
b. in taking the prime responsibility for implementing recall in the situation where it
is necessary.

Records
The Licensee should maintain records for all the pharmaceutical products
manufactured or distributed by them in accordance with the followings:

For manufacturers
- A system should be in operation whereby the complete and up-to-date histories of
all batches of products from the starting materials to the finished products are
progressively recorded;
- The system should allow the determination of utilization and disposal of all starting
materials and bulk products.

For distributors
- Records of all sales or distribution (including professional samples and export to
overseas countries) of pharmaceutical products should be retained or kept readily
accessible to permit a complete and rapid recall of any lot or batch of a
pharmaceutical product.

The complete records pertaining to manufacturing and distribution should be retained

for two years after the date of transaction or one year after the expiry date of the batch
whichever longer.

Besides, the Licensee should retain records of problem reports received about each
product. Problem reports should be evaluated by competent personnel and
appropriate action taken. The evaluation of each report and the action taken should
be shown in the records.

All the above records should be readily available and easy to follow so as to expedite
recall whenever necessary. A copy of manufacturing/ import and distribution records
should be sent to Department of Health when a recall is implemented.

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Recall Procedure
As mentioned in Section B, Licensee should prepare procedures for recall action
which are consistent with the Guidelines and which are applicable to their own
operations. All senior personnel should be familiar with their responsibilities in
connection with the procedure and of the records system for pharmaceutical products.

Problem Reporting
Where evaluation of a problem report concerning pharmaceutical products indicates
that recall may be necessary, the report must be conveyed with the least possible
delay to the Department of Health, including pharmaceutical products that have been
exported-only and not supplied in Hong Kong. Any batch of a formulated product that
has been distributed, or any batch of a starting material that is found not to comply
with the approved product specifications or a relevant standard of PICS, must also be
reported if it has been used in a distributed products.

Recall
Licensee has the prime responsibility for implementing recall action, and for ensuring
compliance with the recall procedure at its various stages (Section B). However, no
recall, regardless of level, should be undertaken without consultation with the
Department of Health.

A responsible officer for recall should be appointed to coordinate the recall and his/her
name and contact phone number should be notified to Department of Health. In
addition, this officer has to report the progress of recall regularly to the Department of
Health.

For Class I recall, Licensee should notify its clients within 24 hours upon the decision
of recall. The company personnel may be utilized to immediately disseminate
information on the recall. This includes telephone advice to quarantine stock pending
recall or possible recall followed by recall letters if necessary. A Recall Reply Form
(Appendix TWO) should be sent to all consignees to confirm quantity of stock on hand
and have all of them returned. The reply form should be kept for inspection by
Department of Health. All Class I recall should complete within a time as found
suitable for the case agreed by Department of Health.

For consumer level recall, the Licensee should set up sufficient recall spots for
collection of recalled products. Information of location of the recall spots, their
operating hours and duration, conditions of refund as well as method of refund should
be noticed to consumers by effective means.

Company representatives may be utilized to recover stock which is the subject of

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recall, providing the provisions are observed in relation to unauthorized possession of
certain stock, e.g. dangerous drugs.

Licensee may also be required to notify overseas recipients of recall actions that
affect them.

Refund Mechanism
Licensee should set up a refund mechanism for the recalled products.

Post-recall
After the timeframe directed by Department of Health to complete the recall, or at
other agreed times, the Licensee is to provide the Department of Health with an
interim report during recall process for the monitoring of progress within 7 days after
initiation of recall. The interim report should contain the following information:
- the number of organizations or persons to whom the defective product has been
supplied;
- the date and means of notifying them of the recall;
- the number of responses received from them;
- the names of the non-responders;
- the quantity of stock returned;
- the quantity of stock has been off shelves pending return to Licensee;
- the estimated time frame for the completion of the recall .

A final report (refer Final Report Form at Appendix THREE) contain the following
information should be submitted to Department of Health within 14 days after
commencing of the recall:
- the circumstances leading to the recall;
- the consequent action taken by the Licensee;
- the extent of distribution of the relevant batch in Hong Kong and overseas;
- the result of the recall
 the quantity of stock returned, corrected, outstanding;
 the quantity of stock used by the consignees and;
 the quantity of stock not located;
 date of recall completion;
- confirmation (using Recall Reply Form at Appendix TWO), where practicable, the
retailers have returned all the recalled products to the Licensee and the customers
have received the recall letter;
- the method of destruction or disposal of the recalled products; and

The licensee should report to Department of Health with relevant explanation and
obtain its approval if the final report cannot be submitted within 14 days after

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commencing of the recall.

After completion of the recall, a report on investigation results on the problem and the
action proposed to be implemented in future to prevent a recurrence of the problem
should be submitted to Department of Health in a timely manner.

These reports establish the effectiveness of the recall and unless satisfactory reports
are received, further recall action may have to be considered.

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H. EVALUATION OF THE RECALL

The evaluation consists of a check on the effectiveness of the recall and an

investigation of the reason for the recall as well as the remedial action taken to
prevent a recurrence of the problem.

Check on the Effectiveness of Recall Action

It is the Licensee responsibility to assure that the recall is effective.

The Department of Health examines the recall reports and the signed Recall Reply
Forms submitted by the Licensee and assesses the effectiveness of the recall action.
Recall records may be inspected and in some case the Department of Health may
contact a percentage of customers in the distribution list as a means of assuring the
Licensee is carrying out its recall responsibilities. If Department of Health finds the
recall to be ineffective, the Licensee will be asked to take appropriate steps, including
re-issuing recall letters.

Investigation of the Reasons for Recall and Initiation of Remedial Action

On completion of a recall, the Licensee is requested to provide a report with
investigation on the problem and details of the remedial action proposed to prevent a
recurrence of the problem which gave rise to the recall (Section G). Where the nature
of the problem and appropriate remedial action are not apparent, investigation and in
some cases Good Manufacturing Practice audits may be necessary.

Where a recall is initiated following a report submitted by a party from overseas health
authorities, the reporter is to be provided with an outline of the results of investigation
and a summary of the recall.

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I. REINSTATEMENT OF SUPPLY

The quality of the products shall conform specific requirements before resuming the
supply to public. The Licensee must seek approval from Department of Health for
reinstatement of the pharmaceutical product previously “totally recalled”.

Implementation of Remedial Action

The Licensee shall identify the root cause of the problem and implement the
corrective action accordingly. Furthermore, preventive action shall be imposed to
prevent recurrence of the problem in the future.

Submission of Analytical Report

After implementing the remedial action and subsequent manufacturing or importing
the new batch of the product, the Licensee shall submit analytical report(s) of the new
batch tested by external accredited laboratory to Department of Health as a proof of
product quality. The submitted report(s) will be evaluated by the Hong Kong
Government Laboratory via Department of Health. After evaluation, Department of
Health would inform the Licensee whether the submitted reports are satisfactory. The
documents relating to submission of analytical report are summarized in Appendix
FOUR.

Sampling
When Department of Health satisfies the submitted reports, sample of the first three
batches of the product (being manufactured by the local manufacturer / being
imported) will be collected for examination by the Hong Kong Government Laboratory.
The Licensee shall notify Department of Health (Please contact Senior Pharmacist
(LC-W) at 3107 3498 (telephone), 3107 0221 (facsimile) or
[email protected] (email address). For emergence notification during
off hours, please contact Senior Pharmacist (LC-W) at 9125 6378) once the
product is ready for sampling. The product can be put on the market only upon
approval for reinstatement from Department of Health is obtained.

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 APPENDIX ONE

PHARMACEUTICAL PRODUCT
PROBLEM REPORT FORM/

RECALL NOTIFICATION FORM

Note:

 Part 1 of this form should be used to report problem of pharmaceutical products on

quality, safety or efficacy, which are thought to have arisen during manufacture,
storage, or handling. Problems of this nature are usually found in a single batch of a
product and may require laboratory investigation by the Department of Health.

 Part 2 of this form should be filled when decision of recall is established.

 When the reported problem may lead to Class I or II recall, it should be reported to
Senior Pharmacist (LC-W) Department of Health within 24 hours by telephone and
following by facsimile or email of this form (Part 1 only).

 If Class I or II recall is required, Part 1 & 2 of this form should be reported to Senior
Pharmacist (LC-W) of Department of Health immediately by telephone and followed
by facsimile or email.

 The Licensee shall NOT wait to submit this information until ALL applicable
information in Part 2 of this form is prepared and assembled prior to notification to
the Department of Health.

 For problem may lead to Class III recall, Part 1 of the form should be returned by
facsimile or by email to Senior Pharmacist (LC-W) no later than 72 hours. When
Class III recall is required, the form (both Part 1 & 2) should submitted by facsimile or
email to Senior Pharmacist (LC-W).

 Please contact Senior Pharmacist (LC-W) at 3107 3498 (telephone), 3107

0221 (facsimile) or [email protected] (email address). For
emergence notification during off hours, please contact Senior
Pharmacist (LC-W) at 9125 6378.

 Use separate form for each pharmaceutical product reported.

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 Attn: Senior Pharmacist (LC-W)
Fax Number: 3107 0221

PHARMACEUTICAL PRODUCT PROBLEM REPORT FORM (PART 1)

DETAIL OF THE PROBLEM
Reporting Company (company reporting the problem of Pharmaceutical Product to DH)
Name of contact Position/ Occupation
Organization
Address
E-mail address
Tel (office) (mobile) Fax
Pharmaceutical product problem occurred in Hong Kong? If not, location of problem:
Nature of the problem
Date of receiving complaint
 Patient  Customer  Retailer  Self-inspection
Source of Complaint
 Other: __________________________________________________
Number of similar reports received
Description of the problem (use separate sheet if space is inadequate)

Results of tests/ investigation on suspect or other samples

Has manufacturer/ distributor been contacted?  No  Yes (please write down their names)

Other relevant information (attach photos, package insert and press release of oversea authority of the
product if any)

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 DETAILS OF THE PRODUCT
Name of the product (as in product registration certificate) HK Registration number

Active Ingredients & Strength

Indications
Dosage form Pack size
Batch number Expiry date
Distribution of products  HA  Private hospitals  Pharmacies  Medicine stores
 DH  Private doctors  Others (specify)
Manufacturer
Name
Address
Tel Fax Manufacture date
Quantity of the batch manufactured Date and quantity released
Quantity on hold Quantity distributed: local
overseas
Importer
Name
Address
Tel Fax Import date
Quantity of the batch imported Date and quantity released
Quantity on hold Quantity distributed: local
re-exported
Local Distributors (please attach distribution list)
No. of local distributors
Name
Address
Contact Person Tel (office & mobile)
Quantity on hold Quantity distributed: local
re-exported
Exporter
Has the product been exported outside Hong Kong?  Yes  No
If yes, specify the exported countries.

Name of Reporter: Post:

Contact no. (mobile): Date:
Signature of Reporter:

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 Attn: Senior Pharmacist (LC-W)
Fax Number: 3107 0221

RECALL NOTIFICATION FORM (PART 2)

RISK ASSESSMENT
Type of hazard  Safety  Quality  Labeling  Compliance Issue
 Other (specify)
Evaluation of Health Hazard to users (e.g. effects on users, possibility of occurrence)
(attached expert advice if any)

Proposed recall classification  Class I  Class II  Class III

PROPOSED ACTION ( WITH AGREEMENT OF DEPARTMENT OF HEALTH PRIOR ACTION)
Recall start date Proposed recall end date
Hotline(s) for enquiry
Hotline(s) operating hours: Mon- Fri Sat Sun & PH
Responsible officer of recall Tel (office & mobile)

Proposed recall level  Wholesale  Retail  Consumer

Location of recall spots (For Consumer level recall only)

Operating hours and duration of the recall spots (For Consumer level recall only)

Means of Refund at the recall spots  Money  Credit Note  Replacement  Other
Conditions of Refund at the recall spots

Proposed recall strategy (use separate sheet if space is inadequate)

Name of Reporter: Post:

Contact no. (mobile): Date:
Signature of Reporter:

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 20
 APPENDIX TWO

RECALL REPLY FORM

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 21
 Recall Reply Form

To :

Attention :
Facsimile
:
Number
Postal Address :

Subject :

From :

Contact person :
Telephone
Number :
Facsimile
Number

We do/ do not * have stock which is subject to this recall.

We have reported and returned all the stock on hand to <Licensee Name>
(* please delete as appropriate)

Stock received:
Batch No. Quantity
Batch No. Quantity
Batch No. Quantity

Unused stock subject to recall (currently in quarantine):

Batch No. Quantity
Batch No. Quantity
Batch No. Quantity

Any other relevant details:

I declare that the information provided by me in this reply form is complete and true to
the best of my knowledge.

Signature: ____________________ Date: ________________________

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 22
 APPENDIX THREE

FINAL REPORT

Note:

 Use separate form for each pharmaceutical product reported.

 This report should be returned by facsimile or by email to Senior Pharmacist (LC-W),

Department of Health within 14 days after commencing of recall.

 Please contact Senior Pharmacist (LC-W) at 3107 3498 (telephone), 3107

0221 (facsimile) or [email protected] (email address).

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 23
 Attn: Senior Pharmacist (LC-W)
Fax Number: 3107 0221

FINAL REPORT FORM

Details of the recalled products
Name of the product HK Registration number
Active ingredients & strength
Dosage form Pack size
Batch number Expiry date
Reasons for recall
Extent of Distribution
Imported/ manufactured quantity
Quantity exported Countries of Export
Quantity distributed in HK No. of Consignee
Action taken by the Licensee

Result of Recall
Quantity of stock returned Quantity of stock outstanding
Quantity of stock used or sold by the consignees
Quantity of stock not located
No. of Recall Reply Form received from consignees on all stock returned/ reported
Disposal Plan
Method of Disposal  Destroy  Return to overseas manufacturer
 Others, please specify:

Details of the disposal method

Licensee Name :
Name of Recall Officer : Signature :
Date :

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 24
 APPENDIX FOUR

DOCUMENTS RELATING TO THE

SUBMISSION OF ANALYTICAL
REPORT

Accredited Test

The laboratory performed the tests should obtain accreditation on the specific test
method in accordance with the international standards e.g. ISO 17025 by third parties
such as the Hong Kong Accreditation Service (HKAS) in Hong Kong or other Mutual
Recognition Agreement (MRA) partners to ensure the its competence in performing
pharmaceutical product testing. The Licensee shall submit the raw data and QC data
for the tested samples to substantiate the validity of test results. These data could
facilitate the Government Laboratory in evaluating the data in the analytical reports.

 List of laboratories which are accredited under the category of pharmaceutical

products in Hong Kong are available in the HKAS websites:
https://www.itc.gov.hk/en/quality/hkas/conformity_assessment_bodies/hoklas.ht
ml
 List of the HKAS MRA partners are available in the HKAS websites:
http://www.itc.gov.hk/en/quality/hkas/doc/common/mramla/MRA_HOKLAS_en.pdf

Non-accredited Test

In case accreditation of the specific test could not be arranged, the analytical report
might be considered acceptable if the laboratory has obtained appropriate
accreditation in the area of pharmaceuticals or pharmaceutical products and be able
to provide necessary documents to prove its competence in respect of their quality
control and technical aspects in performing the specific chemical tests.

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 25
Basically the information should include, but not limited to, the following:
 Detailed method (including standard preparation procedure, sample
preparation procedure, instrument parameters, and quality control procedure
in details);
 Raw data and QC data for all tested samples shown in the report (including
chromatograms, mass spectra and calculation);
 Validation summary for the method used (including method linearity, limit of
detection, limit of quantitation, method bias, precision, and measurement
uncertainty);
 Reference material used and purity verification summary; and
 Relevant proficiency test participated.

Licensee may refer to Technical Criteria for Laboratory Accreditation (HOKLAS 003)
and Supplementary Criteria No. 1, No. 2 and No. 20 published by The Hong Kong
Laboratory Accreditation Scheme (HOKLAS) via the HKAS website at
https://www.itc.gov.hk/en/quality/hkas/publications/hoklas_pub.html

For non-chemical tests, other equivalent technical criteria listed in the website shall be
followed and should be considered on case-by-case basis.

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Pharmaceutical Products Recall Guidelines- 2022 Version Page 26