This document represents a Draft Recall Plan Workbook for participants to use in developing
a recall plan and program for their individual farms.
RECALL PLAN FOR ___________ FARM
This plan addresses the Code of Federal Regulations (CFR), Title 21, Subpart C, Section 7.
“Recall is an effective method of removing or correcting consumer products
that are in violation of laws administered by the Food and Drug
Administration.”
Adapted from
Small Scale Food Producers Association (https://www.ssfpa.net/)
University of Florida (http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf) The Food Recall Manual
Created by Diane T. Ducharme, NCSU GAP Program Coordinator (Diane_Ducahrme@ncsu.edu)
March 2016; with adaptations by Ginger Nickerson, UVM Extension, March 9, 2016
Table of Contents
Introduction ………………………………………………………………………………………….
3
Scope
Recall Policy
General Recall Information ……………………………………………………………………… 3
Why Initiate a Recall
What is a Recall
Types of Recall Classes
Mock Recall
Recall Team
Regulatory Specifics ………………………………………………………………………………… 6
Recall Procedure………………………………………………………………………………………. 7
Recall Procedure Flow Diagram
Recall Plan Checklist………………………………………………………………………………… 10
Appendices:
Appendix A: Customer/Buyer Contact list
Appendix B: Recall Team
Appendix C: Produce Traceability & Mock Recall (SOP)
Appendix D: Recall Log
Appendix E: Example of Information Collected from Consumer
Appendix F: Action Log
Appendix G: Information for FDA Local Coordinator
Appendix H: Traceability Log
Appendix I: Model Recall Notification (via Phone)
Appendix J: Model Recall Notification Letter
Appendix K: Sample Press Release
Appendix L: Product Retrieval Log
Appendix M: Model Recall Return Response Form
Appendix N: Model Recall Envelope
Appendix O: Model Effectiveness Check Response Format (Industry)
Appendix P: Model Effectiveness Check Questionnaire For Telephone Or Personal Visits (Industry)
Appendix Q: Model Effectiveness Check Letter (Industry)
Appendix R: Request for Recall Termination
Appendix S: Restoration Plan
Appendix T: Potential Items for Restoration Plan
Appendix U: Communications Log
Appendix V: Resources to Contact in Case of Recall
References/Resources
2
Introduction
Fill in this section with

Mission statement for your farm

Provide a summary of the acreage, produce, and distribution chains.
Scope
This plan outlines the procedures and forms to use on ______ Farm for a recall, market withdrawal or
mock recall in accordance with 21 CFR Part 7, Subpart C: (21 CFR 7.40-59) Recalls (Including Product
Corrections) – Guidelines on Policy, Procedures, and Industry Responsibility:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=7&showFR=1&subp
artNode=21:1.0.1.1.6.3.
U.S. Food and Drug Administration (FDA) have authority over most other foods, including produce. It is the FDA’s
Guidance for Industry: Product Recalls, Including Removals and Corrections
(http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm) that is being used to help fulfill
FDA’s plans in handling all aspects of a product recall, including all corrections and removals and to facilitate the
development of this plan.
Recall Policy
In the event that a food safety issue arises with our products ______ Farm will protect public health by
facilitating the efficient, rapid identification and removal of unsafe food from the distribution chain and,
by informing consumers (where necessary) of the presence in the market of a potentially hazardous food.
There is a documented recall procedure in place and this will be periodically tested to ensure that it is
comprehensive and fit for purpose in its ability to remove an unsafe product from consumers and/or the
distribution chain.
General Recall Information
Why Initiate a Recall
Product recall is initiated for two reasons:
1. Removal from markets to protect public from products that may cause health problems or
possible death
2. Removal of mislabeled product (false or misleading labeling and/or packaging)
What is a Recall
Recall are the procedures conducted to identify and recover potentially adulterated, misbranded, and/or
hazardous foods from trade and/or consumer channels effectively. Recalls can be voluntary actions by
manufacturers. Manufacturers and/or distributors may initiate a recall at any time to fulfill their
3
responsibility to protect the public health from products that present a risk of injury or gross deception,
or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or
a state agency, in response to a formal request by FDA, or as ordered by FDA. Under FDCA section 423(a),
FDA is required to first give a responsible party the opportunity to cease distribution and conduct a
voluntary recall of an article of food. If the responsible party refuses to or does not voluntarily cease
distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed
under the mandatory recall authority as set forth in FDCA section 423. FDA does have the authority to
seize adulterated products or to acquire an injunction against distribution or may initiate recall process
by informing firm of adulterated product in commerce has been identified.
An effective recall program will protect company employees and brand names from adverse legal,
regulatory and publicity actions. “Natural” occurrences of food contamination have been documented but
prevention is far from 100% achievable! This means preventing purposeful contamination as well. This
is also part of an effective traceability program.
Types of Recall Classes (See Appendix A: Food Recall Terms)
Class 1: a situation in which there is a reasonable probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or death. Examples of this are:

Listeria monocytogenes,

Salmonella,

E. coli O157:H7
Class 2: a situation in which use of, or exposure to, a violative product may cause temporary or medically
reversible adverse health consequences or where the probability of serious adverse health consequences
is remote. Examples of this are:

Hard/sharp foreign objects 7 – 25 mm

Undeclared yellow 5 & 6

Unapproved/uncertified colors

Shigella, staph toxin

Undeclared wheat
Class 3: a situation in which use of, or exposure to, a violative product is not likely to cause adverse
health consequences. Examples of this are:
•
Mold, yeast, lactobacillus
•
Hard/sharp foreign objects less than 7 mm
•
Off odor/off taste from contaminant at levels not likely to pose a hazard to health
Market Withdrawal: Occurs when a product has a minor violation that would not be subject to FDA legal
action. The firm removes the product from the market or corrects the violation. An examples of this is:
•
a product removed from the market due to tampering, without evidence of manufacturing or
distribution problems
4
Mock Recall
A mock recall involves a simulated recall exercise for both your farm and your markets. This is done on a
periodic basis, annual if GAP certified, to evaluate the effectiveness of your plan and procedures. The
process should mimic your actual recall plan. Mock recalls are used to determine whether the recall
procedure is capable of identifying and quickly controlling a given lot of potentially affected product and
reconciling the quantities produced, quantities in inventory, and quantities distributed. A mock recall
will identify potential problems and allow personnel to become familiar with recall procedures. If
problems are identified in the recall procedures, they should be corrected.
Recall Team
It is important to have a team responsible for traceability. The Team is responsible for co-ordinating all
aspects of the product recall. A recall coordinator is to be appointed and members of a recall team
identified from the various functional areas. Together the team will assist the Recall Coordinator in the
event of the recall. All members must ensure that all procedures are carried out effectively and
efficiently. The team is to receive appropriate training so that they understand their responsibilities. The
Recall Management Team list shall be updated at least four times a year to ensure all names, contact
phone numbers and responsibilities of team members and alternates are updated.
For your local recall coordinator, please check the following website:
http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm
For the Northeast Region (New England District) this includes Vermont, Maine, Massachusetts, New
Hampshire, Rhode Island, Connecticut, and New York, the recall coordinator is:
Susan Liner & Pamela Ogonowski
Recall Coordinators
One Montvale Avenue, 4th Floor
Stoneham, MA 02180
Phone: 781-587-7481 (S. Liner)
Phone: 781-587-7449 (P. Ogonowski)
Fax: 781-587-7556
newenglandrecalls@fda.hhs.gov
Regulatory Specifics
According to the 21 CFR Part 7, the recall strategy will take into account the following factors:
1.
2.
3.
4.
5.
Results of health hazard evaluation.
Ease in identifying the product.
Degree to which the product's deficiency is obvious to the consumer or user.
Degree to which the product remains unused in the market-place.
Continued availability of essential products.
FDA will review the adequacy of a proposed recall strategy developed by the recalling firm and recommend
changes as appropriate (more below).
5
A recall strategy will address the following elements regarding the conduct of the recall:
(1) Depth of recall. Depending on the product's degree of hazard and extent of distribution, the recall
strategy will specify the level in the distribution chain to which the recall is to extend, as follows:
(i) Consumer or user level, which may vary with product, including any intermediate wholesale or retail
level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose of a public warning is to alert the public that a product being recalled
presents a serious hazard to health. It is reserved for urgent situations where other means for preventing
use of the recalled product appear inadequate. The Food and Drug Administration in consultation with the
recalling firm will ordinarily issue such publicity. The recalling firm that decides to issue its own public
warning is requested to submit its proposed public warning and plan for distribution of the warning for
review and comment by the Food and Drug Administration. The recall strategy will specify whether a public
warning is needed and whether it will issue as:
(i) General public warning through the general news media, either national or local as appropriate, or
(ii) Public warning through specialized news media, e.g., professional or trade press, or to specific
segments of the population such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks is to verify that all consignees at the recall
depth specified by the strategy have received notification about the recall and have taken appropriate
action. The method for contacting consignees may be accomplished by personal visits, telephone calls,
letters, or a combination thereof. A guide entitled "Methods for Conducting Recall Effectiveness Checks"
that describes the use of these different methods is available upon request from the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
The recalling firm will ordinarily be responsible for conducting effectiveness checks, but the Food and Drug
Administration will assist in this task where necessary and appropriate. The recall strategy will specify the
method(s) to be used for and the level of effectiveness checks that will be conducted, as follows:
(i) Level A--100 percent of the total number of consignees to be contacted;
(ii) Level B--Some percentage of the total number of consignees to be contacted, which percentage is
to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of
the total number of consignees;
(iii) Level C--10 percent of the total number of consignees to be contacted;
(iv) Level D--2 percent of the total number of consignees to be contacted; or
(v) Level E--No effectiveness checks.
As soon as the decision to initiate a recall has been determine, the local FDA District Recall Coordinator will be
contacted. This is prior to issuance of press or written notification to customers.
6
Recall Procedure
This procedure states the action/s ______ Farm will take to effectively manage the recall of a food which
has been determined to be unsafe or unsuitable. A recall plan outlines the flow, procedures and
necessary documents to gather or fill in.
7
Recall Procedure Flow Diagram
Source: http://www.fooddecisionsoftware.com/food_recall_template_downloads
Sources: http://www.fooddecisionsoftware.com/food_recall_template_downloads
8
9
Recall Plan Checklist
Before a Recall



Create a Customer/Buyer Contact list (Appendix A). Be sure to update names, phone numbers, and emails
annually or as needed.
 Restaurants or CSA company: Two contacts in purchasing/shipping department
 Your own CSA: All members by email or website
 Farmer’s Market/Roadside stand: Website for customers to look for information, email sign up sheet,
signs posted at the market or roadside stand
Create a Recall Team and Contact list (Appendix B). This list should include names and phone numbers of
media, representatives, proper authorities (FDA, NCDA, etc.), your insurance company, and your legal
council.
Effective Produce Traceability and Recall procedures and Log (Appendix C & D) have been demonstrated.
A problem has been identified (chemical, physical, or microbial risks) from a consumer complaint, regulator
notification, and internal operations discovery or laboratory reports.






Activate the Recall Team to collect and assess the health risks (Example of Consumer Information shown
in Appendix E)
 Collect information, as needed to address issue. Some examples:
o List of suppliers of product
o Inventory of product – on site, shipped, to retail consumers
o Compliant logs
o Compliance records (e.g., inspections, labs)
o Production logs (e.g., equipment maintenance logs, packing specs, and product specs.)
o Distribution and storage logs
o Employee complaints, sickness or other
 Document with a written log (Appendix F) of dates, times, attendees of any related event or action.
Determine actionable items: Is this a recall? Market withdrawal? Or handled internally by correction
(repairing, relabeling or other adjustments to product), stock recovery (hold on merchandise still under
your control)? (Appendix F)
 Stop production and distribution
 Instruct management & employees to not discard any product
Recall Decide
o Contact local FDA Coordinator addressing intent
o Collect information to specific (Appendix G)
Perform traceback procedures to determine the product (s), Number of units, units of measure, farm,
harvest date, and lot numbers involved (one commodity, or one day all commodities, etc.) (Appendix H)
Collect pertinent documentation regarding the affected product
 Inputs and outputs of affected field associated with the lot number such as notes on flooding, wildlife
activity, ill employees, manure application, etc.
You will need to determine the traceforward (Appendix D)
10





Work with your FDA Local Coordinator and media to initiate necessary recall notice and press release.
(Appendices I - N)
Do a recall assessment. Determine the percent effectiveness of the recall. (Appendices O-Q)
Determine if the recall is over, Recall termination (Appendix R)
Upon completion of the recall, outline and issues in the recall plan and how you should change the recall
plan to make it better
o Root Cause Analysis – Ask WHY? Until you get to the root cause (Appendix S)
Restoration plan from the recall (Appendices S & T)
11
Appendix A: Customer/Buyer Contact list
Customer/Buyer
Name
Address
Email
Business
Phone
Mobile Phone
Product Sold
12
Appendix B: Recall Team
*Core-team members
ROLE
*CEO/Operation
Manager/Owner
NAME
BUSINESS
PHONE
AFTER HOURS
PHONE
RESPONSIBILITIES DURING
RECALL
 Team leader
 Decision Making
Alternate:________
 Obtain/Notify Legal
Counsel
*Production
Manager
Alternate:_____
 Contacting
Production/Distribution/
other Accounts
 Technical Advisory
*Quality
Assurance
Manager
 Quality Assurance /
Technical Advisory
 Complaint Investigation
 Health Departments
Contact
 Coordinates
(microbial)
sample evidence
*Publicity & Public
Relations

Media Communication

Coordinate with work staff
messages
Marketing/advertising
changes
Handles liability questions
and federal and state
responses
Speaks to health & food
safety aspects

*Attorney

Scientific Advisor

Administrative
Support
State Department
of Health
FDA Local Recall
Coordinator a
Insurance
Representative




Assist with paperwork/
documentation, etc.
Coordinate
resources/communication
Notification to FDA of
recall actions
Address any insurance
policies & documentation
a FDA
Local Recall Coordinator: Contact as soon as a decision is made that a recall is appropriate and prior to the
issuance of press or written notification to customers. It is recommended that you do not wait to submit this
information until ALL applicable information is prepared and assembled prior to FDA notification. This "early"
notification will allow FDA the opportunity to review and comment on your written notification and to offer
guidance and assistance in your recall process.
13
Appendix C: Produce Traceability & Mock Recall (SOP)
SAMPLE LANGUAGE FOR TRACEABILITY PLAN
This is sample language. You will need to re-write it so that it is appropriate for what you do at your farm.
TRACEABILITY
Our traceability and recall programs are closely related.
Trace back records
Our farm utilizes a traceability system that allows us to trace product one step forward and one step back. We keep
records of all of our agricultural inputs including soil amendments, fertilizers, seeds/transplants, and agricultural
chemicals so that we can link them with each of our crop types and ultimately, if necessary, to the buyer(s).
[DESCRIBE YOUR SYSTEM HERE – THIS IS AN EXAMPLE – YOUR SYSTEM AND THE INFORMATION YOU RECORD MAY BE
DIFFERENT]
1. All products produced by the farm will be assigned a traceability code (Lot number) based on harvest date, crop, and
field number.
2. Harvested product will be tagged, stamped or labeled by marketing unit (Examples: bin, box, case, pallet, bag, etc.)
to show the following information:
a. The type of crop
b. The name and address of our farm
c. The field the crop was grown in [IF APPLIES]
d. The harvest date [OR PACK DATE- WHICHEVER YOU USE ON YOUR LABELS]
e. The lot number [IF USED]
3. All product is invoiced as it is shipped from the farm.
4. Invoices include: farm name and information, buyer name and information, and inventory amounts transferred/
exchanged.
5. Invoice should be signed or initialed by the customer (receiving party) when product is delivered.
6. All unused/unsold inventories is accounted for including quantity, date and method of disposal.
We use a lot number system that identifies the harvest date and field (Example: 072414-2 means harvested on July 24,
2014 from field 2. Adding any other information that you use in your lot tracking system.)
When we make a sale, the invoice includes information on boxes shipped, to whom, the date of shipment, and the
harvest date and field code number. We keep copies/have electronic copies of all invoices so that the buyer and we
have the same information.
If a product is comingled during or after harvest, the above label information for EACH crop type and block of land is
provided to the buyer.
Trace forward and mock recalls exercise
Once during each growing season, we conduct a trace forward/mock recall exercise to verify that we can match each lot
sold to the specific buyer and that we can recall product if needed. As part of the exercise, we contact a buyer to identify
a load received from our company. We ask how much of the product has been sold, how much they have in inventory
and if any has been disposed for other reasons (fell on floor, etc.). This information is recorded on our Mock Recall form
and kept on file (document). We keep a record of contact information for each of our buyers (document). After a
selected lot is sold and shipped, we go through our records to verify that we can match each box shipped to each buyer
it was shipped to.
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Our goal is to achieve 100% effectiveness of reconciliation of product to recipients within ___ hours. The percent
effectiveness of the recall is calculated in the following way:
A= total amount of product
B= amount still in inventory
C= amount delivered to customers
D = incidental usage if any (e.g. product dropped on ground, etc.…)
(B+C+D) / A x 100 = % effectiveness of recall
The goal of the exercise is to demonstrate that we have open communication pathways with our buyers and that,
should it be necessary, we can work with our buyers to remove any of our shipped products from their inventory.
15
Appendix D: Traceability/Mock Recall Log
Date:
Product
Buyer/Customer name:
ID/Lot
#
Harvest
Date
Ship
Date
Amt.
Shipped
&
PO #
Indicate
container
type
Date &
Time
Buyer
Contacted
Buyer contact info:
Amt. of
Product
Remaining
in Buyer
Possession
Amt. of
Product
Sold by
Buyer to
Who
Amt. of
product
returned/
destroyed
Initials
Comments:
Determine the percent effectiveness of the (mock) recall
The total amount of suspect product must equal the sum of the product shipped and the amount still in
inventory.
A – total amount of product produced
B – Amount still on inventory
C – Amount delivered to customers
D – Incidental usage (product dropped on ground, etc.)
* This recall Log is used for EACH buyer AND one for company’s on-premises inventory (not distributed & in
storage).
16
Appendix E: Example of Information Collected from Consumer
This form is available at: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
Source: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
17
Appendix F: Action Log
This checklist is designed to be a general “log of actions” that includes all major actions and requirements.
It may easily be adapted in greater detail to a company’s specific Recall Plan. You can download a clearer
version from: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
18
Source: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
19
Appendix G: Information for FDA Local Coordinator
As soon as the decision to initiate a recall has been determine, the local FDA District Recall Coordinator should
be contacted. This is prior to issuance of press or written notification to customers.
FDA recommends the inclusion of the following information in your recall submission:
1. PRODUCT INFORMATION:
 Product name (include brand name and generic name)
 Description of the product
o
o
o
o
o
Include if product is powder, liquid, tablet, capsule, etc.
Include the intended use or indications.
If the product is perishable, include the expected shelf life.
Include type of packaging (i.e. box, flexible plastic, glass).
TWO COMPLETE SETS OF ALL
labeling to your Local FDA District Recall Coordinator. Include:
o Product labeling (including ALL private labels)
o Individual package label
o Case label (photocopy acceptable)
o Package Inserts
o Directions for Use
o Promotional Material (if applicable)
2. CODES (Production Identification Numbers):
 Lot/Unit Numbers
(NOTE: If "all lots" are involved or the product is not coded, explain how non-recalled, or reintroduced
product may be distinguished from product subject to recall. Provide an explanation of your lot
number coding system.)
 Expiration date(s) or Use by date(s) or Expected shelf life of product.
 UPC codes
3. RECALLING FIRM:
 Firm name, address, city, state, zip code
 Identify firm type (i.e. manufacturer, importer, broker, repacker, own-label distributor)
 CONTACTS for Recalling Firm:
o
o
o
Name/title/phone/fax number/e-mail address for RECALL contact
Name/title/address/phone/fax number of the most responsible individual for the recalling firm
Name/title/phone/fax number/e-mail address for public contact
4. MANUFACTURER (if applicable)
20
o
o
Firm name, address, city, state, zip code
FDA registration number, if applicable
5. IDENTIFY FIRM RESPONSIBLE FOR THE VIOLATION/PROBLEM:
o
Firm name, address, city, state, zip code
6. REASON FOR THE RECALL:
o
Explain in detail how product is defective and/or violative.
o
Explain how the defect affects the performance and safety of the product.
o
If the recall is due to the presence of a foreign object, describe the foreign objects' size,
composition, hardness, and sharpness.
o
If the recall is due to the presence of a contaminant (cleaning fluid, machine oil, paint vapors),
explain level of contaminant in the product. Provide labeling, a list of ingredients and the Material
Safety Data Sheet for the contaminant.
o
If the recall is due to failure of the product to meet product specifications, provide the
specifications and report all test results. Provide copies of any sample analysis.
o
If the recall is due to a label/ingredient issue, provide and identify the correct and incorrect label(s),
description(s), and formulation(s).
o
Please explain how the problem occurred and the date(s) it occurred.
o
Explain how the problem was discovered and the date discovered.
o
Please explain if the problem/defect affects ALL units subject to recall, or just a portion of the units
in the lots subject to recall.
o
Explain why this problem affects only those products/lots subject to recall.
o
Provide detailed information on complaints associated with the product/problem:
o
Date of complaint
Description of complaint -include details of any injury or illness
Lot Number/Serial Number involved
If a State agency is involved in this recall, identify Agency and contact.



7. HEALTH HAZARD ASSESSMENT:
o
Please provide your assessment of the health risk associated with the deficiency.
NOTE: A recall decision does not depend solely on the health risk of the product. Defective
products and misbranded products where no health hazard exists are still in violation of the law
and should be recalled.
21
8. VOLUME OF RECALLED PRODUCT:
o
o
o
o
o
o
o
o
Total quantity produced
Date(s) produced
Quantity distributed
Date(s) distributed
Quantity on HOLD by Recalling firm and its distribution centers.
Indicate how the product is being quarantined
Estimate amount remaining in marketplace
 distributor level
 retail level
Provide the status/disposition of marketed product, if known, (e.g. used,
used in further manufacturing, or destroyed).
9. DISTRIBUTION PATTERN:
o
o
Number of DIRECT accounts (customers you sell directly to) by type, for example:
 wholesalers/distributors
 repackers
 manufacturers
 consumers (direct, internet or catalog sales)
 state or federal government consignees
 foreign consignees (specify whether they are wholesale distributors, retailers or users)
Geographic areas of distribution, including foreign countries.
o
Provide a consignee list (names/address/city/state/contact name/phone number) to the local
District Recall Coordinator. Be sure to include any foreign (including Canadian) customers and
federal government consignees (USDA agencies, Veterans Affairs, Department of Defense)
o
Indicate what the consignee list represents (i.e. all customers who were shipped
recalled product; all customers who were sold recalled product; all customers who may have been
shipped or sold recalled product because it was sold to them within the applicable time period.)
o
Was product sold under a government contract? If yes, provide contract number, contract date and
implementation date. If no, indicate so.
o
Was product sold to any federal, state, or local agency involved in the school lunch program? If yes,
list the consignees and provide quantity and sale and shipment date.
In addition, it is recommended that you notify both "ship to" and "bill to" customers of the recall so that
o
o
"Ship to" customers retrieve the product from their location.
"Bill to" customers, if responsible, initiate the subrecall.
10. RECALL STRATEGY:
o
Indicate the level in the distribution chain to which you are extending the recall. (i.e.
wholesale/retail/pharmacy/medical user)
If your recall only extends to the wholesale/distributor level, we recommend that you explain your
rationale for not recalling to retail/pharmacy level.
22
o
Indicate the method of notification (i.e. mail, phone, facsimile, e-mail). It is advisable to include a
written notification so customers will have a record of the recall and your instructions.
o
Indicate how letters will be sent to customers (e.g. overnight mail, first class mail, certified mail,
facsimile)
o
If initial notification is by phone, provide a copy of the phone script to FDA.
o
If you have a web site, you should consider posting the recall notification on the web site as an
additional method of recall notification. (Note: This is not recommended as a sole means of
customer notification.)
o
Report on what you have instructed customers to do with the recalled product.
o
It is helpful for recalling firms to know the name and title of the Recall Contact for each of its
consignees. Addressing a recall notification letter to a recall contact will expedite the recall process
and reduce the potential for the notification letter to get misdirected.
o
If product is to be returned, explain the mechanics of the process.
o
Explain if this recall will create a market shortage that will impact on the consumer.
o
Report on recall effectiveness check strategy. Include your actions for non- responders. See:
<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm>
o
Determine and provide your course of action for out-of-business distributors.
o
Provide a proposed method of destruction, if applicable.
o
If the product is to be "reconditioned", explain how and where the reconditioning will take place.
Please provide details of the reconditioning plan to your local FDA District Recall Coordinator
before implementation. All reconditioning must be conducted under any applicable CGMPs.
o
Describe how reconditioned product will be identified so it is not confused with recalled (prereconditioned) product.
In addition, we recommend that:
o
You contact your local FDA District Recall Coordinator prior to product destruction. FDA will review
your proposed method of destruction and may choose to witness the destruction.
o
The recalling firm and customers keep adequate documentation of product destruction (and
whether or not destruction was witnessed by an FDA investigator).
o
Field corrections, (i.e. product relabeling), be performed by recalling firm representatives, or under
their supervision and control. It is not recommended that a disinterested party such as a
wholesaler or retailer be responsible for field corrections. For Drug Recalls: Misbranded drugs for
re-labeling should be returned to the recalling firm.
o
You contact your local District Recall Coordinator prior to release of reconditioned goods.
23
Appendix H: Traceability Log
SHIPPED TO
Product:
Lot Number/
Code/Date:
Lot
Quantity:
Name/Location:
Date
Shipped:
Quantity
Left OnFarm:
Quantity Shipped
and Requiring
Recovery:
TOTAL=
24
Appendix I: Model Recall Notification (via Phone)
The following information is to aid you when contacting people to recall your product. Fill out one sheet for
each group contacted.
This is (Name of Recall Coordinator)_______________________________________________________.
I am calling from (Your Operation’s Name) ________________________to notify you that all product (Lot
#)_____________________on (Date/Time) __________________needs to be returned, destroyed, modified,
etc._________________________________________________________________________.
I have the following questions to ask you about this recall:
1. Who do I speak to about a recall and what is their contact information?
Contact (Name): _______________________________________________________________________
Phone Number: ________________________________________________________________________
Fax Number: __________________________________________________________________________
Title: ________________________________________________________________________________
2. Do you have any of the product(s) being recalled? (If no, terminate questioning.) YES / NO
If the answer to question #2 is YES, the product must be returned, destroyed, modified, etc.
_____________________________________________________________________________________
3. The return, destruction, modification, etc. of this product will be dealt with by action intended:
_____________________________________________________________________________________
4. Have you received any reports of illness or injury related to this product? YES / NO
If YES, please provide details.
____________________________________________________________________________________________________________________________________
______________________________________
Confirmation Signature: __________________________ Date: _________________________________
25
Appendix J: Model Recall Notification Letter
Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
Salmonella Model Press Release
FOR IMMEDIATE RELEASE
COMPANY CONTACT AND PHONE NUMBER
DATE
FOOD CO. RECALLS PRODUCT BECAUSE OF POSSIBLE HEALTH RISK
Company Name of City, State is recalling Quantity and/or type of Product, because it has the potential to be
contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young
children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with
Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In
rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and
producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and
arthritis.
Product was distributed Listing of states and areas where the product was distributed and how it reached
consumers (e.g., through retail stores, mail order, direct delivery).
Specific information on how to identify the product (e.g., the type of container [plastic, metal, glass], size
and appearance of the product, the product's brand name, flavor, code and expiration date, etc.).
Status of the number of and types of related illnesses that have been CONFIRMED to date (e.g., "No
illnesses have been reported to date.").
Brief explanation about what is known about the problem, such as how it was revealed, and what is known
about its source. An example of such a description -- "the recall was as the result of a routine sampling
program by the company which revealed that the finished products contained the bacteria. The company
has ceased the production and distribution of the product as FDA and the company continue their
investigation as to what caused the problem."
Information on what consumers should do with the product and where they can get additional information
(e.g., "consumers who have purchased Brand X are urged to return it to the place of purchase for a full
refund. Consumers with questions may contact the company at 1-800-XXX-XXXX.)
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011)
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
26
Appendix K: Sample Press Release
Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
( SAMPLE PRESS RELEASE)
XYZ Inc.
123 Smith Lane
Anywhere, MS
FOR IMMEDIATE RELEASE
Sam Smith /555-555-5555
DATE
XYZ RECALLS "SNACKIES" BECAUSE OF POSSIBLE HEALTH RISK
XYZ Inc. of Anywhere, MS, is recalling its 5 ounce packages of "Snackies" food treats because they have the
potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal
infections in young children, frail or elderly people, and others with weakened immune systems. Healthy
persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting
and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into
the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms),
endocarditis and arthritis.
The recalled "Snackies" were distributed nationwide in retail stores and through mail orders.
The product comes in a 5 ounce, clear plastic package marked with lot # 666666 on the top and with an
expiration date of 12/12/99 stamped on the side.
No illnesses have been reported to date in connection with this problem.
The potential for contamination was noted after routine testing by the company revealed the presence of
Salmonella in some 5 ounce packages of "Snackies."
Production of the product has been suspended while FDA and the company continue their investigation as to
the source of the problem.
Consumers who have purchased 5 ounce packages of "Snackies" are urged to return them to the place of
purchase for a full refund. Consumers with questions may contact the company at 1-800-XXX-XXXX.
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011)
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
27
Appendix L: Product Retrieval Log
Quantity
Shipped and
Requiring
Recovery
Date/ Time
Person
Contacted:
Quantity
Recovered
or
Destroyed:
Quantity
Remaining
With
Contact:
Action Taken and
Description (e.g., picked
up, returned, destroyed,
etc.):
Quantity Recovered:
TOTAL = (Total to equal the total on Form 2)
Appendix M: Model Recall Return Response Form
Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
NOTE: This MODEL is intended to serve as guidance for recalling firms. It may not conform to your firm's recall
strategy. Please make any appropriate modifications to the response form. IT IS ADVISABLE TO SUBMIT THE
PROPOSED RECALL LETTER AND RESPONSE FORM TO YOUR LOCAL FDA RECALL COORDINATOR FOR REVIEW,
PRIOR TO ISSUANCE.
<COMPANY LETTERHEAD>
<insert product>
<insert lot numbers>
Please check ALL appropriate boxes.
 I have read and understand the recall instructions provided in the <date> letter.
 I have checked my stock and have quarantined inventory consisting of _____ <units or cases>.
 Indicate disposition of recalled product:
 returned (specify quantity, date and method)/held for return;
 destroyed (specify quantity, date and method);
 relabeled (specify quantity and date);
 quarantined pending correction (specify quantity);
 I have identified and notified my customers that were shipped or may have been shipped this product by (specify
date and method of notification); <or>
Attached is a list of customers who received/may have received this product. Please notify my customers.
Any adverse events associated with recalled product? __Yes __ NO
If yes, please explain: _____________________________________________________
Please check the appropriate box(es) to describe your business





wholesaler/distributor _ retailer
grocery corporate headquarters _ food service/restaurant
repacker
manufacturer
Other: __________________________________________________________
Name: ____________________________________
Title: ____________________________________
Tel. number: (
) ______________________________
Firm name: __________________________________________
address: __________________________________________
city/state: __________________________________________
PLEASE FAX COMPLETED RESPONSE FORM TO Tel. # < >, ATTN: < >
OR MAIL TO: FIRM NAME AND ADDRESS
Appendix N: Model Recall Envelope
Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
FIRST CLASS MAIL
JOHN DOE
Somewhere, U.S.A. 12345
A. B. C. Retail Company
Anywhere, U. S. A.
(red print) URGENT: RECALL
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011)
http://www.fda.gov/Safety/Recalls/IndustryGuidance/
2
Appendix O: Model Effectiveness Check Response Format
(Industry)
Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
Consignee Name and Address
(Pressure Sensitive Label)
Recall Effectiveness
Checks-Mail Method
JOHN DOE PRODUCT RECALL
________________________________________________________________________
PLEASE READ EACH QUESTION AND CHECK THE PROPER ANSWER YOU HAVE CHOSEN. PLEASE CHECK
WITH ANYONE WHO MAY HAVE RECEIVED THIS NOTIFICATION BEFORE ANSWERING.
DATE_______________
1. Did your firm receive notification that the John Doe Company is recalling its ______(Name)______ product?
YES_____ NO_____
2. Did your firm receive shipments of the product being recalled?
(If no, please sign and return).
YES_____ NO_______
3. Do you now have any of the recalled product on hand? (Please check inventories
before answering).
YES______ NO_______
4. If the answer to question 3 is YES, do you intend to return the product to the John
Doe Company as requested?
YES_______ NO______
5. If the answer to question 4 is NO, please explain your intentions.
6. Have you received any reports of illness or injury related to this product?
YES_______ NO________ If yes, please provide details.
Name of person completing questionnaire:_______________________________________
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011)
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
3
Appendix P: Model Effectiveness Check Questionnaire For
Telephone Or Personal Visits (Industry)
Consignee Name and Address
(Pressure Sensitive Label)
JOHN DOE PRODUCT RECALL
After contacting the consignee and locating the person responsible for handling recall notifications and/or the
product involved, an opening similar to the following may be used.
This is (Name of Interviewer). I am calling for (recalling firm) to check on the effectiveness of the company recall of
(product description, including codes). On (date), (recalling firm) notified (how: letter, telephone, visit, mailgram,
etc.), all firms which may have purchased (product) that all stock should be (returned, destroyed, modified,
relabeled, etc.). I have the following questions to ask you about this recall:
DATE_____________
1. Did your firm receive notification that (product name) products manufactured by
John Doe Company are being recalled?
YES______ NO______
2. Did your firm receive shipments of the product being recalled? (If no, terminate
questioning and go to the closing).
YES______ NO_______
3. Do you have any of the recalled product on hand? (Please check inventories before
answering).
YES______ NO________
4. If the answer to question 3 is YES, do you intend to return the product to the
John Doe Company as requested?
YES_______ NO________
5. If the answer to question 4 is NO, please explain your intentions
_______________________________________________________________________
6. Have you received any reports of illness or injury related to this product?
YES_______ NO________
If yes, please provide details.
Thank you for your cooperation.
And your name is ________________________________________________
And what is your title please?_______________________________________
Interviewer____________________________
Date__________________________________
IF RESPONDENT HAS ANY FURTHER QUESTIONS, ASK HIM/HER TO CONTACT THE JOHN DOE COMPANY,
SOMEPLACE, SOMEWHERE 12345
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011)
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
4
Appendix Q: Model Effectiveness Check Letter (Industry)
NOTE: If this letter is sent to distributors who may have further sold the product to other distributors or to retail outlets, the third
paragraph should include the fact that the recall notice requested the direct consignees to conduct sub-recalls by notifying their
customers of the recall situation.
Consignee
Name and Address
Date
(Pressure Sensitive Label)
Dear Sir:
On (date), you were notified by letter that John Doe Company, Someplace, Somewhere 12345, is recalling
(product name), container size, code number. All products were manufactured by John Doe Company and
distributed solely under the manufacturer’s label.
Recall of the product was initiated following [INSERT YOUR EXPLANATION FOR WHY PRODUCT WAS
RECALLED]
The recall notice from John Doe Company requested consignees (wholesalers and retailers) to
discontinue selling their existing stock of the old formulations and return existing inventories of the
recalled formulations to John Doe Company.
In order to advise the Food and Drug Administration about the effectiveness of this John Doe Company
recall, you are requested to complete and return the enclosed questionnaire promptly using the prepaid
self-addressed envelope.
If you have any questions or problems with this request, please call (name and telephone number).
Thank you for your cooperation.
Sincerely,
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011)
http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
5
Appendix R: Request for Recall Termination
This form is available at: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
6
Appendix S: Restoration Plan
1. Why was there a recall? (E.g., What was the source of the problem?)
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
2. What corrective action(s) was/were taken? (List and describe)
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
3. What ongoing procedures did you put in place to prevent the recurrence of the problem?
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
4. Identify the person(s) responsible for ensuring the above actions and procedures are monitored and
implemented.
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
Confirmation Signature:____________________________ Date: ________________
7
Appendix R: Potential Items for Restoration Plan
Source: GA Department of Agriculture
8
Appendix U: COMMUNICATIONS LOG
Company or
Organization
Contact
By
Phone
By
Email
In
Person
Recall Team
Member
Copy Reason or
on
Description
File
9
Appendix V: Resources to Contact in Case of a Recall
Vermont Department of Health
Main Number - Call: 802-863-7200
In Vermont 800-464-4343
http://healthvermont.gov/contact/contact.aspx
Elisabeth Wirsing
Program Chief
Food & Lodging Program
elisabeth.wirsing@vermont.gov
Address: 359 South Park Drive
Colchester, Vermont 05446
Phone: 802-338-4724
Fax: 802-338-4706
Emergency: 802-863-7200
Vermont Agency of Agriculture
(802) 828-2430
AGR.Helpdesk@vermont.gov
Kristina Sweet
Vermont Agency of Agriculture, Food, and Markets
kristina.sweet@state.vt.us
(802) 522-7811
Food and Drug Administration
For the Northeast Region (New England District) this includes Vermont, Maine, Massachusetts, New Hampshire,
Rhode Island, Connecticut, and New York, the recall coordinator is:
Susan Liner & Pamela Ogonowski
Recall Coordinators
One Montvale Avenue, 4th Floor
Stoneham, MA 02180
Phone: 781-587-7481 (S. Liner)
Phone: 781-587-7449 (P. Ogonowski)
Fax: 781-587-7556
newenglandrecalls@fda.hhs.gov
UVM Extension Produce Safety Programs
GAPs and Produce Safety Coordinator
Ginger Nickerson
gnickers@uvm.edu
802-656-5459
CAPS – Community Accredited Produce Safety
Hans Estrin
Hans.estrin@uvm.edu
10
Grower Associations
Vermont Vegetable and Berry Association
http://www.uvm.edu/vtvegandberry/?Page=WelcomeVVBGA.html
NOFA- VT and Vermont Organic Farmers
Address: 39 Bridge St, Richmond, VT 05477
Phone:(802) 434-4122
Testing labs – see separate sheet in back of manual
Media
WCAX
Burlington, VT 05406-4508.
Primary Phone: 802-652-6300.
Primary email: channel3@wcax.com.
Vermont Public Radio
(802) 655-9451
http://www.vpr.net/inside_vpr/contact_us/
Times Argus
802-479-0191 General Number
802-223-3931 Vermont Press Bureau
Vermont Digger
Anne Galloway, executive director of Vermont Journalism Trust and editor of VTDigger, can be reached at:
802-225-6224 (office)
802-222-6086 (google voice)
802-595-9159 (mobile)
agalloway@vtdigger.org.
press releases and commentaries to pressrelease@vtdigger.org
11
References/Resources:
US Code of Federal Regulations Title 21
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=7&showFR=1&subpartNod
e=21:1.0.1.1.6.3
Model Press Release Guidance is available on the FDA website
at: http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
FDA DISTRICT RECALL COORDINATORS
A current list of FDA recall coordinators can be found on FDA’s website at:
http://www.fda.gov/Safety/Recall/IndustryGuidance/ucm129334.htm
The Food Recall Manual – IFAS(FSHN – 04-10) https://edis.ifas.ufl.edu/fs108
California Public Health Dept Recall Template:
https://www.cdph.ca.gov/pubsforms/Documents/fdbRIgde23.pdf
12