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Recall Program Template

This document provides a sample template for a product recall plan. It outlines key roles and responsibilities in the event a recall is necessary. The template includes guidance on classifying the severity of the recall, notifying customers, tracking recalled products, disposing of recovered products, investigating the root cause, and preparing information for the FDA. It also defines Class I, II, and III recall classifications and provides details on when to report to the Reportable Food Registry.

Uploaded by

Janara Aline Rocha
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
213 views

Recall Program Template

This document provides a sample template for a product recall plan. It outlines key roles and responsibilities in the event a recall is necessary. The template includes guidance on classifying the severity of the recall, notifying customers, tracking recalled products, disposing of recovered products, investigating the root cause, and preparing information for the FDA. It also defines Class I, II, and III recall classifications and provides details on when to report to the Reportable Food Registry.

Uploaded by

Janara Aline Rocha
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Company LOGO Here

Document
Manufactured by Company name, address, phone # and brief description Issue Date
Revision Date
Approval Date
Approval Signature
Recall Program – Sample Template

Recall Members Position Phone # Cell #

If a recall is deemed necessary, Members will immediately assess the type of hazard posed by the product. Information gathering
may require independent laboratory analysis, evaluation of customer complaints and examination of production batches from the
starting material to finished product. Recall will be classified as a Class I, II or III according to the severity of the problem. The
Food and Drug Administration (FDA) will be notified if our firm initiates a recall.

We will immediately cease distribution and sales of the affected product; quarantine product remaining in our possession and
notify customers that have received affected products.

Customers will be notified, preferably, via FedEx or by phone or email. Follow-up letters will be sent to non-responding
customers.

Recall product will be broken down as follows:

 Total quantity of the recall product originally in our possession.


 Total quantity distributed at the time of the recall
 Total quantity remaining in our possession

Recovered product may be corrected, reprocessed or destroyed under the supervision of the insert name of applicable department
– example: Quality Control Department. The insert name of applicable department – example: Quality Control Department
may elect to seek advice from the insert applicable State Department of Agriculture and The Food and Drug Administration.

Root cause of the problem will be examined and Corrective Actions taken.

The Following information will be ready for the FDA District Office:

 Identity of the product, brand name and container size


 Copies of pertinent labels
 Codes or Lot numbers affected by the recall
 Reason for the recall
 Date and circumstances under which product deficiency was discovered
 How the Evaluation Risk was made
 Recalled product breakdown
 The number of direct accounts where affected product was distributed, including names and contact information
 Copy of recall communication letter.
 Proposed recall strategy
 Contact person who will speak to FDA and other health officials

Recall Communication Letter must include:

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Company LOGO Here
Document
Manufactured by Company name, address, phone # and brief description Issue Date
Revision Date
Approval Date
Approval Signature
Recall Program – Sample Template

 Identity of product with code information


 Reason for recall
 Notification that further distribution or use of any remaining product should CEASE Immediately
 Instruction for Customer to notify any of its customer, down the line, if they received any of the product
 Specific instruction for what to do with the product
 A postcard for customers to report back to us
 For a Class I and II Recall Letter should be marked URGENT
 A telephone script similar to the recall information should be used when calling customers
 Recall effectiveness checks will be done by letter, phone email or in person

Recall Classification:

 Class I:
Dangerous and defective product that could cause serious health problems or death.
Examples: Foods contaminated with Salmonella, E. Coli, Listeria Monocytogenes, undeclared Allergens.

 Class II:
Product might cause a temporary health problem or pose only a slight threat of a serious nature.
Examples: Undeclared Yellow # 5, presence of Foreign Objects, such as pieces of plastic).

 Class III:
Product is unlikely to cause any adverse health problems but violates labeling or manufacturing laws.
Examples: Insufficient weights, lack of English labeling.

Reportable Food Registry (RFR) is a portal where the industry must report when there is a reasonable probability that an article of
food will cause serious adverse health consequences or death to humans or animals (reportable food).

Within 24 hours of determining or being notified that a facility has or has had a reportable food in its possession, the facility must
submit a report to FDA through the Department of Health and Human Service’s Safety Reporting Portal at:

 WWW.SAFETYREPORTING.HHS.GOV

OR

 WWW.FDA.GOV/REPORTABLEFOODREGISTRY.

THE FDA Registration number will be required to submit a report.

 Insert Company Name - FDA Registration #: Insert FDA Registration # here

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