The document outlines the process for terminating a drug recall at the FDA. It discusses how the district recall coordinator will submit a termination recommendation in the Recall Enterprise System (RES) and notify the Center Recall Unit (CRU). The CRU will then review the information, update the recall status to "terminated" in RES, and notify the district office and Office of Enforcement that the recall has concluded. The typical goal is to terminate a recall within three months of the firm completing all recall actions.

1. TERMINATION OF RECALL

2.  RECALL ENTERPRISE SYSTEM (RES)
 CENTER RECALL UNIT (CRU)
 HEALTH HAZARD EVALUATION
 RECALL INITIATION
 RECALL CLASSIFICATION
 ALERTING THE PUBLIC
 MONITORING RECALL EFFECTIVENESS
 TERMINATION OF RECALL

3.  A drug recall is the most effective way to protect the
public from a defective or potentially harmful product.
 A recall is a voluntary action taken by a company at any
time to remove a defective drug product from the market.

4. RECALL ENTERPRISE SYSTEM (RES)
 The Recall Enterprise System (RES) is an
electronic data system used by FDA recall
personnel to submit, update, classify, &
terminate recalls.
 The RES increases efficiency in processing recall
information by:
– Allowing field coordinators to input recall
information via on-line, internet system;

5. -Using a uniform Health Hazard Evaluation (HHE)
form;
-Providing the public with “real-time” information
about the FDA recall process.

6. CENTER RECALL UNIT(CRU)
The Center recall unit:
1. Initiates a health hazard evaluation (HHE)
2. Finalizes a recall strategy
3. Classifies the recall and, for Class I recalls, and,
4. Updates RES with classification, audit strategy,
and any recommendations, and posts the
information to the internet.

7. HEALTH HAZARD EVALUATION
 Population
 Seriousness of hazard
 Likelihood of occurrence of hazard
 Immediate and long term consequences

8. RECALL INITIATION
Recall may initiated in two ways:
1. Firm initiated Recalls: A manufacturer or distributor
may voluntarily initiate a recall at any time.
2. FDA requested Recalls: Under certain urgent situations,
FDA may request that a manufacturer or distributor
recall a product.

9. RECALL CLASSIFICATION
Numerical designation (i.e., I, II, or III) is
assigned by FDA to a particular product recall to
indicate the relative degree of health hazard
presented by the product being recalled.

10. ALERTING THE PUBLIC
 FDA seeks publicity about a recall only when it believes
the public needs to be alerted to a serious hazard.
 When a recalled product has been widely distributed, the
news media is a very effective way to reach large
numbers of people.
 FDA can hold press conferences, issue press releases,
and post updates to its Web site regularly, to alert people.

11. MONITORING RECALL EFFECTIVENESS
 FDA evaluates whether all reasonable efforts have been
made to remove or correct a product.
 A recall is considered complete after all of the
company's corrective actions are reviewed by FDA
and deemed appropriate.
 After a recall is completed, FDA makes sure that the
product is destroyed or suitably reconditioned, and
investigates why the product was defective.

12. TERMINATION OF RECALL
 FDA will terminate a recall when the monitoring
district office determines that the recalling firm
has completed all recall activity, including
monitoring and final product disposition.
 The district will notify the recalling firm by a
letter that FDA considers the recall terminated.

13.  District recall coordinator will enter the
information required for termination in RES on
the “Summary & Termination “ page then verify
the information then send an email to the CRU
recommending termination.

14.  Upon receipt of the termination recommendation email,
the CRU will access RES, review the termination
information and change the “recall status” field to
“terminated” and generates an email to the district and
OE/DCMO advising that the recall is terminated.
 As a rule FDA should terminate the recall within three
months after the firm completes the recall.

15. Office of Enforcement / Division of Compliance
Management and Operations
 OE/ DCMO is the agency’s headquarters contact
and focal point for information, advice, and
direction for field recall operations and remains
involve with each recall throughout its process.

16. SUMMARY OF TERMINATION OF
RECALL

17. Monitoring district office
District office will notify the recalling firm by a letter that FDA considers the application
District recall coordinator will enter the information required for termination in RES on the
“Summary & Termination “ page then verify the information then send an email to the CRU
recommending termination
Then District recall coordinator will send an email to the CRU recommending termination
CRU will access RES, review the termination information and change the “recall status” field to
“terminated”
CRU will send an email to the district office and OE/DCMO advising that the recall is
terminated