Page 1 of 13  WORKING DRAFT AS OF 15 DEC 2023  1 
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FDA CIRCULAR  3 
No: ___________  4 
  5 
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SUBJECT  : Guidelines on  the Recall  of Health Products Regulated by the Food and 7 
Drug  Administration  8 
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I. RATIONALE  11 
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Republic Act (RA) No. 9711 otherwise known as the “Food and Drug Administration Act 13 
of 2009” and its Implementing Rules and Regulations (IRR) were enacted to establish an 14 
effective regulatory system for the authorization, registration, and monitoring of health 15 
products. Pursuant to Section 2 (i), Article II, Book I, the Food and Drug Administration 16 
(FDA)  is mandated  to require  all manufacturers,  traders,  distributors,  importers,  exporters, 17 
wholesalers,  retailers,  consumers,  and non-consumer  users  of health  products  to report  any 18 
incident that a product has caused or contributed to the death, serious illness or serious 19 
injury to a consumer, patient, or any person. Likewise, Section 5 (k) of the same law 20 
empowers the FDA, after due process, to order the ban, recall, and/or withdrawal of any 21 
health product found to have caused the death, serious illness or serious injury to a 22 
consumer or patient, or is found to be imminently injurious, unsafe, defective, ineffective, 23 
and/or grossly  deceptive.  24 
 25 
Part of the larger Post Marketing Surveillance (PMS) scheme of FDA is Product Recall, 26 
which  enables  the retrieval  of imminently injurious, unsafe,  defective, ineffective,  and/or  27 
grossly  deceptive  health products from the distribution chain that may present a health 28 
hazard to the consumer or user. Hence,  FDA  Circular  (FC) No. 2016 -012 or the 29 
“Guidelines  on Product  Recall”  was issued to prescribe guidelines on the conduct of 30 
Product Recall and outline the responsibilities  of the FDA and Marketing Authorization 31 
Holder (MAH) on FDA -regulated  products.  32 
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Since the implementation of this issuance , the globalization of trade, harmonization of 34 
standards, and the advent of electronic commerce facilitated the flow of goods. 35 
Meanwhile, the scope of products regulated by the FDA has since expanded and its 36 
processes digitized and updated to be at par with internationally -accepted practices. 37 
Regulatory oversight has since been more complex, and thusly urged regulatory 38 
authorities to seek strategic and more effective methods to safeguard public health and 39 
improve consumer awareness. The role of the industry as product stewards are more 40 
emphasized in this globalized and digital environment. The regulatory landscape of 41 
health products has changes significantly that the initially issued Guidelines on Product 42 
Recall needs to be revised. Thus, this  Circular is hereby promulgated to create an updated 43 
framework for  the recall  of products,  reflecting  this evolving  landscape,  in pursuit  of 44 
public  health  and safety.  45 
 46 
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Page 2 of 13  II. OBJECTIVES  1 
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This Circular intends to establish  a guideline  on the recall of health products and 3 
effectively contribute in ensuring the safety and protection of the general public  which 4 
present a substantial risk of injury, illness, and/or gross deception. Specifically, this 5 
Circular aims to:  6 
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A. Strengthen the recall system for health products under the jurisdiction  of the FDA;  8 
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B. Specify the responsibilities and reporting obligations of the MAH in the conduct of 10 
product recall;  and 11 
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C. Provide guidance to MAH in conducting effective  recalls.  13 
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III. SCOPE  16 
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A. This shall cover all  licensed manufacturers (including packers/repackers, 18 
refurbishers of medical devices), traders, distributors (importers, exporters, 19 
wholesalers)  of health products, drug outlets (drugstore, pharmacies – community 20 
or institutional or boticas, retails outlets for non -prescription drugs (RONPD), and 21 
retailers of medical devices.  22 
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B. This shall apply to all  authorized health products under the jurisdiction of the FDA, 24 
namely:  25 
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1. Human drug products , veterinary drug products, non -medicated veterinary 27 
products, medical  devices  for veterinary  use, medical  oxygen,  traditional  28 
medicines,  vaccine  and biological products, herbal medicines, and home 29 
remedies  under  the Center for Drug Regulation and Research  (CDRR);  30 
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2. Pre-packaged processed food products, food supplements, food additives, and 32 
raw materials under the Center for Food Regulation and Research (CFRR);  33 
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3. Cosmetics, household/urban hazardous substances, household/urban pesticides, 35 
toys and childcare articles, and tobacco products  under the  Center for Cosmetics 36 
and Household/Urban Hazardous Substances Regulation and Research 37 
(CCHUHSRR);  38 
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4. Medical devices, health -related devices, radiation -emitting devices, and in -vitro 40 
diagnostic  devices  under  the Center  for Device  Regulation,  Radiation Health and 41 
Research (CDRRHR); and  42 
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5. Other products that may have an effect on health which require regulations as 44 
determined by the  FDA.  45 
 46 
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IV. DEFINITION OF  TERMS  48  
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For the purpose  of implementing  this Circular,  the following  terms  are hereby  defined  for 2 
greater  clarity:  3 
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A. Authorized Health Product s refers to FDA -registered product that has a valid or 5 
active FDA authorization.  6 
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B. Center  refers to the  FDA  Centers , namely : CDRR, CFRR, CCHUHSRR and  8 
CDRRHR.  9 
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C. Consumer  refers  to the individual  member  of the general  public  purchasing  or 11 
using products for private  purposes.  12 
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D. Establishment refers to a sole proprietorship, a partnership, a corporation, an 14 
institution, an association, or an organization engaged in the manufacture, 15 
importation, exportation, sale, offer for sale, distribution, donation, transfer, use, 16 
testing, promotion, advertising, or sponsorship of health products, including the 17 
facilities and installation needed for its activities.  18 
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E. FDA -Ordered or Mandatory Recall refers to a recall ordered or directed by the 20 
FDA to  MAH who does not initiate a recall.  21 
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F. Health Hazard Evaluation  refers to the assessment of the product recall 23 
committee to the hazards presented by a product which determined the risk to the 24 
public and the necessary actions, including the commencement of a recall that may 25 
be undertaken to address the  risk. 26 
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G. MAH -Initiated or Voluntary Recall refers to the prompted removal of health 28 
product from the supply chain, such as manufacturers, wholesalers, retailers, or 29 
retrieval from consumers or third -party users, initiated by the MAH.  30 
 31 
H. Marketing Authorization Holder  (MAH)  refers to the company, corporate or 32 
legal entity that is responsible for all aspects of the product, including quality and 33 
compliance conditions of the marketing authorizations. The MAH may either be a 34 
manufacturer, trader, distributor, or  retailer.  35 
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I. Product Recall Committee  (PRC)  refers to the authorized member from the 37 
different FDA Offices responsible for the investigation of triggers, review of 38 
product  recall reports  and strategies,  and the general  oversight  of the recall  system  of 39 
health  products.  40 
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J. Product Recall Resolution (PRR)  refers to the formal statement of decision 42 
agreed at a duly convened meeting in which representatives exercise the power of 43 
voting on a comprehensive detailed of risk.  44 
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K. Recall  refers  to a method  of retrieval  of imminently injurious, unsafe,  defective,  46 
ineffective,  and/or  grossly deceptive products from the distribution chain that may 47 
present a health hazard to the consumer or user.  48  
Page 4 of 13   1 
L. Recall  Strategy  refers  to a planned  course  of action  to be taken  in conducting  a 2 
recall, which addresses the depth of recall, need for public warnings, extent of 3 
effectiveness checks, among  others.  4 
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M. Risk Assessment refers to the process of harm and risk identification, analysis, and 6 
evaluation.  7 
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N. Risk Classification refers to the numerical designation to indicate the relative 9 
degree of health hazard presented by the product being recalled.  10 
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O. Risk Management Plan  (RMP) refers to the document that contains a set of health 12 
product vigilance activities and interventions designed to identify, characterize, 13 
prevent, or minimize  risks  relating  to health  products,  and the assessment  of 14 
effectiveness  of those interventions.  15 
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P. Supply Chain  refers to the network that designs, manufactures, imports,  17 
distributes, and sells a  product.  18 
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Q. Third -party User  refers to a person other than the consumer who interacts with the 20 
product.  21 
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R. Traceability  refers to the ability to follow the movement of a health product 23 
through specified stages of the supply chain such as, but not limited to , production, 24 
manufacturing, storage, distribution, retail outlets, and consumers.  25 
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V. GENERAL  GUIDELINES  28 
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A. Only health products which adhere to safety, efficacy, and/or quality standards of 30 
the FDA, bearing the proper authorizations, may be placed in the Philippine  market.  31 
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B. Health  products  bearing  non-conformances  to FDA  standards  on safety,  efficacy,  33 
and/or quality which present a substantial risk of injury, illness or deception to the  34 
consumers and/or third -party users shall be subject to the recall system as stated in 35 
this Circular.  36 
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C. The FDA shall, in parallel, institute a PMS system that will allow the detection of 38 
triggers for recall, assessment of health hazards, and the recommendation and/or 39 
order of correction of products which present a substantial risk of injury, illness or 40 
deception to the consumers and/or third - party  users.  41 
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D. The overall responsibility of conducting a recall lies with the MAH, including 43 
compliance  with the required  reporting  and communication  activities in 44 
accordance with this Circular . MAH  are expected  to be prepared in the event of a 45 
recall, having in place a system as part of their overall RMP , to detect triggers for 46 
recall, activate recall activities by trained and competent personnel, enable the 47  
Page 5 of 13  traceability of affected products, notify consumers and/or third -party users, and 1 
monitor and evaluate the effectiveness of  recall.  2 
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E. When  a decision  to recall  is made,  the MAH  shall notify the FDA and provide all 4 
available relevant information in accordance with this Circular . The  information 5 
required to adequately identify the product and the product recall strategy 6 
(including the communication and effectiveness check plans) shall be submitted to 7 
the FDA.  8 
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F. All measures must be exhausted by the MAH to communicate the conduct of recall, 10 
the hazard and/or deficiency, and/or available remedies to consumers and/or third - 11 
party users. The FDA shall similarly announce recalls to consumers through the 12 
issuance of public health warning, alert,  advisory, or other suitable  means.  13 
 14 
G. The FDA throug h the established  Product Recall Committee (PRC)  shall perform 15 
the oversight of  the recalls  in accordance  with this Circular . The FDA PRC  shall directly 16 
report to the Office of the Director General all activities, status, and actions taken on all recall as 17 
prescribed in this issuance.   18 
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H. In the event that the MAH fails to initiate a recall and/or adequately conduct a 20 
recall, the FDA  PRC shall not be precluded from intervening and commencing 21 
further regulatory actions . The decisions provided by the FDA  PRC may be 22 
appealed through the Office of the Director General in order to ensure public health 23 
and safety.  24 
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I. The FDA  shall  conduct  the necessary inspections and audits to ensure the 26 
effectiveness of the product recall strategies of  the MAH.  27 
 28 
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VI. SPECIFIC  GUIDELINES  30 
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A. FDA Product Recall Committee  32 
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1. An FDA PRC shall be created in each Center by way of an FDA Personnel Order 34 
(FPO) composed, at the minimum, of the following  members:  35 
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a. Director;  37 
b. Division Chief, Licensing and Registration Division  (LRD);  38 
c. Division Chief, Product Research and Standards Development Division 39 
(PRSDD);  40 
d. Senior Officer from the Common Services Laboratory  (CSL);  41 
e. Senior Officer from the Legal Services Support Center  (LSSC);  42 
f. Senior Officer from the Field Regulation Operations Office  (FROO);  43 
g. PRC Secretariat from PRSDD;  and 44 
h. Medical Doctor and Pharmacovigilance Staff, for  CDRR.  45 
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2. The FDA PRC shall have the following roles, responsibilities, and  functions:  47 
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Page 6 of 13  a. Notify and submit recall report to the Office of the Director General and 1 
provide regular updates  to the current status of the recall, actions taken, and 2 
progress made .  3 
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b. Manage the recall system of the products under the jurisdiction of their 5 
respective  Centers;  6 
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c. Call upon  the MAH to  a conference  to discuss  recall  reports  and strategies to 8 
maximize recall  effectiveness;  9 
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d. Process and review recall reports submitted by MAH, including the conduct 11 
of health hazard evaluation/risk assessment, classification of product  recalls,  12 
development  of recommendations  to improve  product  recall strategies;  13 
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e. Oversee  the review  of triggers  emanating  from  the PMS activities, perform 15 
the necessary health hazard evaluation/risk assessment, investigations, 16 
classify recalls, recommend the issuance of Product Recall Order (PRO) and  17 
other regulatory actions;  18 
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f. Develop and maintain a recall communication system with the assistance of 20 
all concerned FDA Centers and Offices.  21 
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g. Coordinate with the appropriate government agencies and international 23 
bodies for matters related to recalls, including the dissemination of safety 24 
alerts, as necessary;  25 
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h. Monitor  and evaluate  the compliance  of on-going  recalls  in accordance  with 27 
these Circular, and applicable rules and regulations ; 28 
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i. Develop databases, forms, guidelines, and procedures consistent with this 30 
Circular ; and 31 
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j. Perform other activities as deemed necessary for the effective 33 
implementation of this  Circular . 34 
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B. Types of Recall   36 
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1. Product Recall is categorized based on the source of the decision to recall:  38 
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a. MAH -Initiated or Voluntary Recall , shall be done by the manufacturers, 40 
traders, and distributors of health products when they decided to and/or have 41 
withdrawn their product from any of the stages of the supply chain due to 42 
any safety and/or quality reason.  43 
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b. FDA -Ordered or Mandatory Recall , shall be done when the evaluation by 45 
the PRC shows that there is reason to believe that a health product can be 46 
imminently injurious, unsafe, defective, ineffective, and/or grossly 47 
deceptive, and when the MAH fails to initiate a recall.  48  
Page 7 of 13   1 
C. Procedures on MAH -Initiated or Voluntary  Recalls  2 
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1. Reporting Obligations. When the MAH decided to conduct a recall, the MAH 4 
shall immediately notify the FDA and provide all available relevant information.  5 
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a. Contents of the  Report  7 
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i. Identity of the MAH and Person Responsible for the Recall , 9 
including name, complete address, and contact  details ; 10 
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ii. Identification of the Product , including product name,  description 12 
(dosage form, intended use or indication, shelf -life, expiration,  type 13 
of packaging, product registration/notification number), 14 
batch/lot/consignment codes, quantity of products implicated,  name 15 
and complete  address  of manufacturer,  copy  of commercial  labeling 16 
(all labels, including inserts and  tags) ; 17 
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iii. Reason for Recall , including nature of problem/hazard, date and 19 
time at which  the problem  was identified,  how the problem  occurred 20 
and the dates it occurred, extent to which the problem affects all or a 21 
portion of the units/lots subject of recall, details of reported 22 
complaints/adverse  events ; 23 
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iv. Results of the Health Hazard Evaluation/ Risk Assessmen t, assessment 25 
of the problem and measures  taken ; 26 
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v. Recall Strategy , including the depth of recall, scope of recall, 28 
communication plan, recall effectiveness strategy, proposed  method 29 
for destroying or correcting the  product ; 30 
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vi. Distribution Details , including description of distribution channels 32 
(name and address of distributors and retailers, quantity , and 33 
batch/lot/consignment codes of the products  distributed) ; and  34 
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vii. Other Information , including results of tests performed  and other 36 
pertinent information that may be deemed necessary for inclusion in 37 
the report . 38 
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b. Timing of the Report. The MAH  shall notify the FDA no longer than 40 
twenty -four (24) hours  from  its decision  to make  a recall  or from  the time it 41 
receives information from their principal that a product they placed in the 42 
Philippine  market  is subject  to a recall.  The completeness  of the information 43 
shall not in any way delay the submission of the Report. In all cases, the 44 
information contained in the Report shall be completed within ten (10) 45 
working days upon filing the report to the FDA  through  a supplemental  46 
filing.  47 
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Page 8 of 13  c. Submission of  Report  Notification  1 
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i. The MAH  shall  file the report  through the Food and Drug Action Center 3 
Office  (FDAC)  at info@fda.gov.ph , copy furnish the Office of the 4 
Director General at odg@fda.gov.ph . 5 
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d. Review  and Classification of Recall  7 
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i. The FDA  through the PRC of the concerned Center, shall conduct a 9 
review of the submitted report, evaluate possible health hazards, and 10 
recommend the classification of recall according to risk as follows : 11 
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(1) Class I Recall – product defects/conditions that are potentially 13 
life threatening or could result to severe health risk, health 14 
impairment or effects such as permanent damage to health or 15 
death, and/or grossly deceptive.  16 
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(2) Class II Recall – product defects/conditions that could cause 18 
poisoning or temporary/medically reversible  adverse  health  19 
problem  or mistreatment  or where probability of life threatening or 20 
severe  health risks is  remote.  21 
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(3) Class III Recall – product defects/conditions that may  not pose a 23 
significant  hazard  to health,  but recall may have been initiated for 24 
other  reasons.  25 
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ii. The classification  of the recall and any other directive  to improve the 27 
recall strategy indicated in a PRR shall be discussed and communicated 28 
with the MAH  through conference  within  forty -eight (48) hours  from  the 29 
receipt of the complete report. The FDA PRC shall not be precluded to 30 
further shorten or change timelines and to call upon the MAH in order 31 
to establish measures to mitigate risks to public health and  safety.  32 
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2. Communication  Requirements.  Communication  activities  of product  recalls  shall 34 
be in accordance with the following  rules:  35 
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a. The MAH shall ensure that all communications are clear, consistent, and 37 
accurate, such that intended consumers , third -party users , and other 38 
establishments in the supply chain  understand the risk entailed in the 39 
product recall and the necessary steps they need to undertake to minimize 40 
such risk. Communications must be designed and written in a manner that 41 
does not downplay  the hazard  or in a language  that makes  an involved  party 42 
less likely to participate in the  recall.  43 
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b. A communication  plan shall be  submitted  by the MAH as part of the product  45 
recall  strategy.  This shall include the following  information:  46 
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Page 9 of 13  i. Identification of communication  channels ; and  1 
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ii. Template documents, including press releases and recall notices 3 
wherein the minimum information required for any communication 4 
is provided in Annex  A. 5 
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c. For Class I and II recalls, the MAH shall promptly notify all concerned 7 
parties (e.g., establishments involved in the supply chain, hospitals, outlets, 8 
and health facilities, healthcare professionals, consumers, third -party users, 9 
general public) on the product recall within twenty -four (24) hours at the 10 
time a risk of injury, illness, and/or gross deception is identified, copy 11 
furnishing the FDA.  12 
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For Class III recalls, the MAH shall promptly notify all concerned parties 14 
(as mentioned above) within seventy -two (72) hours.  15 
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d. The FDA shall issue the specific public health warnings, alerts, and other 17 
advisories in order to  inform consumers  and/or third -party users , and other 18 
establishment in the supply chain of violative products subject  of recall, for 19 
the purposes of protecting public health and  safety.  20 
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i. The FDA shall issue a public health warning  for Class I and Class  II 22 
Recalls.  23 
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ii. Public  health  warning  for Class  III Recalls  shall  be issued  based  on 25 
the health hazard evaluation and recommendations made by the 26 
FDA  PRC.  27 
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iii. The FDA shall also endeavor to publish a list of product recalls, 29 
including the status of such recalls  in a suitable and accessible 30 
platform.  31 
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3. Recall Effectiveness Checks. Activities to check the effectiveness of recalls shall 33 
be in accordance with the following  rules:  34 
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a. MAH  shall check and monitor the effectiveness of recalls  to ensure that 36 
consumers , third -party users, and all establishments in the supply chain have 37 
received the communication and have acted or participated accordingly in 38 
the recall. Monitoring plans for effectiveness checks shall be part of the 39 
recall  strategy.  40 
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b. A recall status report shall be submitted by the MAH to the concerned FDA 42 
PRC providing the updates consistent with the submitted monitoring plans 43 
for effectiveness.  The frequency of reporting should be based on the product 44 
recall strategy of the MAH. The minimum information that shall form part 45 
of the recall status report is provided in Annex  B. 46 
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c. The FDA shall perform activities, including but not limited to: inspection to 48  
Page 10 of 13  verify and monitor implementation of the recall; visits to consumers; third - 1 
party users;  and other establishments in the supply chain to check 2 
dissemination of recall communications and level of recall participation; 3 
visits to MAH to follow -up corrective action; verification checks of disposal 4 
or destruction activities; analyses of samples; and other activities to check 5 
and verify the effectiveness of recalls, including its  completion.  6 
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4. Recall Completion and Termination. The cessation of active recall operations 8 
based on recall completion and the subsequent recall termination shall be in 9 
accordance with the following  rules:  10 
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a. The MAH shall consider the following factors before making a decision to 12 
cease active recall  operations:  13 
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i. Objectives of the recall have been  met; 15 
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ii. There  is a high level  of confidence  that a large  proportion  of affected 17 
consumers have received recall communications and have 18 
participated in the  recall;  19 
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iii. There  are no longer  any complaints  and/or  reports  of injuries  and/or 21 
illnesses;  22 
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iv. There are appropriate levels of returns commensurate to the nature 24 
of the health hazard and  risk; and  25 
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v. 100% of identified distributors and retailers with affected products 27 
have participated and returned all their remaining stocks . 28 
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b. The completion of a recall shall be reported to the FDA through a final 30 
status report. In the same submission, the MAH may request for the 31 
termination of the recall by complying with the procedures and the 32 
submission of documentation as provided in Annex  C. 33 
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c. A recall  will be terminated  by the FDA  when  the FDA  PRC  determines  that 35 
all efforts have been made to remove or correct the health product in 36 
accordance with the recall strategy, and when  the product subject to the 37 
recall has been removed and proper disposition has been made 38 
commensurate with the degree of hazard of the recalled  product.  39 
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d. In the event that a co nsumer or a member of the general public make a 41 
request  on the information of completion and/or termination of a recall, such 42 
request shall be in adherence with the existing rules and regulations on the 43 
freedom of information.  44 
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5. Recall Readiness. MAH shall  be prepared  in the event of a product recall in 46 
accordance with the following  rules:  47 
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Page 11 of 13  a. MAH  shall have a recall system in place as one of their risk management 1 
tools in the  RMP . The recall  system  shall  ensure  that processes  are in place to  2 
prevent  product -related  incidents  that could  lead to a recall,  including  the 3 
trigger detection, incident investigation, and health hazard evaluation/risk 4 
assessment . 5 
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b. The recall system sh all allow the operation and activation of recall activities  7 
by a recall  management  team  comprising  of trained  and authorized personnel 8 
which have competencies and roles in recall coordination and leadership, 9 
technical/engineering, operations, sales and marketing, risk management, 10 
legal, and  communications.  11 
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c. The recall system shall incorporate procedures for the adequate  monitoring 13 
and evaluation of the effectiveness of recall. It is recommended for MAH to 14 
conduct simulation of recall protocols, as resources would  allow.  15 
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d. The MAH shall have a system in place that allows for the traceability of 17 
affected products and the notification of consumers, third -party users, and 18 
other establishments in the supply  chain.  19 
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e. Mock recall shall be carried out on a yearly basis to assess the effectiveness 21 
recall system put in place. Any gaps found in the system during the mock 22 
recall shall be appropriately addressed so that operation can be activated 23 
immediately and promptly during an actual recall.  24 
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D. Procedures on FDA -Ordered  or Mandatory Recalls  26 
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1. Triggers for product recall may result from  Pharmacovigilance (PV) , defective 28 
reports from reputable sources (e.g., ASEAN Post - Marketing Alert System or 29 
PMAS) and/or PMS activities of the FDA . The FDA shall follow its existing 30 
guidelines on product recall.  31 
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2. In instances where an MAH has not initiated a recall for an unsafe, defective, 33 
ineffective and/or grossly deceptive product, the FDA may issue a recall order to 34 
the MAH and follow procedures of its recall authority under Section 5(k) of RA 35 
No. 9711. If, after providing the MAH an opportunity to consult with the agency, 36 
and find that there is reasonable probability that the health product would cause 37 
serious illness or injury , the FDA may order the MAH of such product to initiate a 38 
recall. FDA -Ordered Recalls shall be subjected to the same rules as provided for in  39 
‘Subsection C Procedures on MAH -Initiated or Voluntary  Recalls’  above.  40 
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3. In instances  where  the MAH  refuses  to conduct  the mandatory recall  or fails to 42 
effectively  implement the agreed product recall strategy, the FDA shall perform the 43 
necessary regulatory actions,  including  the seizure,  quarantine,  destruction  and/or  44 
disposal  of the unsafe, defective,  ineffective,  and/or  grossly  deceptive  product  at the 45 
expense  of the MAH.  46 
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E. Reconsideration on the Recall Order  48  
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1. The MAH may opt to request for administrative reconsideration of the recall order 2 
with the FDA Office of the Director General thru a formal request for 3 
reconsideration within fifteen (15) calendar days after receipt of a copy of the recall 4 
decision . Extension for filing of the request for reconsideration shall be 5 
entertained.   6 
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2. The applicant shall point specifically the findings or conclusions stipulated in the 8 
Recall Order which are not supported by facts, rules, or technical standards.   9 
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3. The FDA shall resolve the request for reconsideration within twenty (20) calendar 11 
days from receipt of the request for reconsideration.   If the request for 12 
reconsideration is denied, the applicant may perfect an appeal before the Office of 13 
the Secretary of Health during the remainder of the period for appeal, reckoned 14 
from receipt of the resolution of denial.   The procedure on appeal prescribed by the 15 
Department of Health or the Administrative Code of 1987 shall apply.   16 
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4. The FDA shall transmit the records of the product recall upon perfection of the 18 
appeal and order from the Department of Health.   19 
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5. The decision of the FDA or DOH  may be subject to judicial review in accordance 21 
with the Administrative  Code of 1987 and applicable laws.   22 
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6.  The FDA shall publish and make available for public inspection of all final 24 
decisions of product recall,  subject to the rules on Freedom of Information and Data 25 
Privacy.    26 
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7. For the above purpose, the FDA shall endeavor to prepare a register or compilation 28 
of those decisions or final orders or reports.   29 
  30 
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VII. PENALTY  CLAUSE  32 
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Violations of any provision of this  Circular, in line with the provisions of Republic Act 34 
No. 3720 and Republic Act No. 9711 and its IRR shall be a ground for the filing of 35 
appropriate administrative charges that could lead to the imposition of administrative 36 
sanctions such as, but not limited to, imposition of fines, suspension, cancellation, or 37 
revocation of any market authorization issued by FDA.  38 
 39 
The following activities shall merit the imposition of penalties subject to the filing of 40 
appropriate administrative charges:  41 
 42 
A. Failure to report a recall within the timelines provided in this  Circular;  43 
B. Failure to initiate and conduct a recall in accordance to the Product Recall Strategy 44 
approved by the FDA  PRC;  45 
C. Refusal to initiate and conduct a recall ordered by the FDA;  46 
D. Failure to issue recall communications in accordance with the requirements and 47 
timelines provided in this  Circular;  48  
Page 13 of 13  E. Failure  to submit  recall  status  reports  in accordance  with the requirements  and 1 
timelines provided in this  Circular;  2 
F. Failure to conduct the disposition activity approved by the  FDA;  3 
G. The distribution, sale, resale, offer for sale, promotion, and/or advertisement of any 4 
recalled product;  and 5 
H. Other analogous grounds or causes as determined by the  FDA.  6 
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VIII.  MONITORING AND REVIEW  9 
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This Circular shall be reviewed and evaluated within three (3) years of its implementation 11 
to determine whether the policy's objectives, impact, and effectiveness are achieved.  12 
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IX. SEPARABILITY  CLAUSE  15 
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If any part, term, of provision of this Circular shall be declared invalid or unenforceable, 17 
the validity or enforceability of the remaining portions or provisions shall not be affected 18 
and this Circular shall be construed as if it did not contain the particular invalid or 19 
unenforceable or unconstitutional part, term, or provision.  20 
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X. REPEALING  CLAUSE  23 
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FDA Circular No. 2016 -012, entitled,  “Guidelines  on Product  Recall”  is hereby repealed . 25 
Other related issuances inconsistent or contrary to the provisions of this Circular  are 26 
hereby repealed accordingly.  27 
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XI. EFFECTIVITY  30 
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This Circular shall take effect after fifteen (15) days following the publication in the 32 
Official Gazette or in a newspaper of general circulation and filing with the Office of the 33 
National Administrative Register of the UP Law Center.  34 
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DR. SAMUEL A. ZACATE  37 
                                                                                                                     Director  General  38 
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