2. TABLE OF CONTENTS:
I. Recall Page # 3
II. FDA responsibilities Page # 4
i. Responsibilities of OE/DCMO Page # 5
ii. Responsibilities & procedures - OE/DCP Page # 6
iii. Responsibilities & procedures – OE/DCIQA Page #6
III. Recall Enterprise System (RES) Page # 7
IV. Center Recall Unit (CRU) Page # 8
V. Health Hazard Evaluation (HHE) Page # 9
VI. Recall Initiation Page # 10
VII. Recall Classification Page # 11
i. Class I Recall Page # 12
ii. Class II Recall Page # 13
iii. Class III Recall Page # 14
VIII. Alerting the public Page # 15
IX. Monitoring Recall Effectiveness Page # 16
X. Termination of Recall Page # 17-18
XI. Responsibilities of Recalling Firm Page # 19
i. Preparing of the Recall Page # 20
ii. Determining the Scope of the Recall Page # 21
iii. Determining the Depth of the Recall Page # 22
iv. Communicating with FDA Page # 23
v. Communicating with Consignees Page # 25
vi. Press release Page # 25
XII. Drug Recalls in 2013. Page # 26-28
07/15/13
2
3. RECALL
• Recall means a firm’s removal or correction of a
marketed product(s) that the Food and Drug
Administration considers to be in violation of the
laws it administers and against which the agency
would initiate legal action, e.g., seizure.
OR
• Recalls are an alternative appropriate method of
removing or correcting marketed consumer products,
their labeling, and/or promotional literature that
violates the laws administered by FDA.
07/15/13 3
4. FDA RESPONSIBILITIES
• FDA is involved in recall procedures.
• Monitor the recall by reviewing firm’s status reports and conducting audit checks
(District)
• Discuss and approve recall strategy –including press releases (District/Center
-Office of Public Affairs for press)
• Classify the recall (Center)
• Terminate the recall (District Class II and III; Center approval for class I)
• FDA will take appropriate regulatory action or other measures when the firm fails
to recall violative product or when a recall action fails.
• These actions will be taken in consultation and coordination with the district
compliance branch, the appropriate center recall and compliance staffs, OE/DCMO
and when indicated, the officer of Chief Counsel, when:
– A firm refuses to recall or sub-recall after being requested to do so by FDA;
– A firm fails to complete recall in a timely fashion;
– The agency has reason to believe that a recall strategy is not effective.
07/15/13 4
5. • Responsibility of 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.
–If required, it may direct appropriate follow up actions by the
field.
–It periodically reviews all agency recall activities to ensure that
current policy & procedures are being applied to recalls and
recommends changes are appropriate.
–It informs OE/DCIQA of recalls that may affect govt. agencies.
–It evaluates the overall effectiveness of recall activities.
–It communicates trends, common cause of recalls, control
weakness, etc., having the needs for this information.
07/15/13 5
6. • Responsibilities & Procedures - Office of Enforcement/
Division of Compliance Policy
–OE/DCP reviews and resolves compliance policy issues related to
recalls.
–The division reviews recall action memorandums when requested
by OE/DCMO.
–OE/DCP provides written response to OE/DCMO.
• Responsibilities & Procedures - Office of
Enforcement/Division of Compliance information &
Quality Assurance
–OE/DCIQA receives recall information from OE/DCMO when the
identified consignees include government agencies.
–It forwards the information, as appropriate, to the applicable
government agencies.
07/15/13 6
7. RECALL ENTERPRISE SYSTEM
• 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;
– Allowing users to build a record of the entire recall by entering information as
it becomes available thus reducing preparation time and providing consistency
throughout the agency;
– Reducing duplication of efforts between the Field officer, OE, the centers, and
Office of public affairs;
– Increasing communication of recall information between field, headquarters
and the appropriate center(s) office;
– Using a uniform Health Hazard Evaluation (HHE) form or a form equivalent to
HHE form to promote consistency in evaluating potential health hazards;
– Providing the public with “real-time” information about the FDA recall
process.
07/15/13 7
8. 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,
prepares an Action memorandum for Center
Director or his/her designee concurrence before
forwarding it to OE/DCMO and the ACRA; and,
4. Updates RES with classification, audit strategy,
and any recommendations, and posts the
information to the internet.
07/15/13 8
9. HEALTH HAZARD
EVALUATION
•Diseases or injuries which have already occurred
•Existing conditions that can contribute to a clinical
condition
•Population
•Seriousness of hazard
•Likelihood of occurrence of hazard
•Immediate and long term consequences
07/15/13 9
10. RECALL INITIATION
• Recall may initiated in three 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.
3. FDA Ordered Recalls: Under certain authorities, FDA
may mandate a recall. It includes:
– Mandatory Device recalls
– Mandatory of biological products
– Mandatory recall of human tissue intended for transplantation
– Infant formula
– Interstate milk shipments
– Tobacco products
07/15/13 10
11. 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.
07/15/13 11
12. • CLASS I RECALLS
Class I is 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 Class I Recalls
•Pathogens in ready-to-eat food: Salmonella, Listeria
monocytogenes, E. coli, Clostridium
•High levels of sulfites
•High levels of heavy metals
•Choking hazards for susceptible populations
07/15/13 12
13. • CLASS II RECALLS
Class II is 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 Class II Recalls
•Foreign objects that pose a physical hazard
•Pathogens: Shigella, hepatitis A, Cyclospora, Cryptosporidium
07/15/13 13
14. • CLASS III RECALLS
Class III is a situation in which use of, or exposure to, a violative
product is not likely to cause adverse health consequences.
• Example of Class III Recalls
An example might be bottles of aspirin that contains 90 tablets
instead of the 100 stated on the label.
07/15/13 14
15. 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.
• Not all recalls are announced in the media. But all recalls go into FDA's
weekly Enforcement Report. This document lists each recall according to
classification, with the specific action taken by the recalling firm.
• "It's about being as transparent as possible," says Catherine McDermott,
public affairs manager in the Division of Federal-State Relations in FDA's
Office of Regulatory Affairs. "If we feel there is that much of a health risk,
we will offer media updates every day to give new information, and all that
we know gets posted to FDA's Web site."
07/15/13 15
16. 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
in the first place
• A recalling firm may be unable to check the effectiveness of its recall when
a recall extends to the consumer-user level, the confidential business
record of a firm’s customers are not accessible, wholesalers, distributors or
retailors do not cooperate, or because an urgency of the situation requires
an all-out effort.
• In such cases, when a recalling firm unable to check its effectiveness, FDA
will directly assist in this activity and, where necessary, seek assistance
from cooperating state and local agencies.
07/15/13 16
17. 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.
• Termination of Class I recall and a Safety Alert requires center
concurrence. When the monitoring district concludes that such
a recall and a Safety Alert has been completed, the 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.
07/15/13 17
18. • 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
• Center approval is not required for Class II and III recall
terminations.
• As a rule FDA should terminate the recall within three months
after the firm completes the recall.
07/15/13 18
20. Preparing for a recall
• Review available recall guidance
• Develop a recall plan
• Maintain manufacturing and distribution records in a
manner to facilitate a timely and effective recall
• Identify finished products with a lot number/code
07/15/13 20
21. Determining the scope of the
recall.
•When did the problem start/end?
•Can additional lots/products be affected other than the
lot/product analyzed and found adulterated?
•How many sizes/labels for the product?
•Is the product coded with a lot number?
•Shelf life of product
07/15/13 21
22. Determining the depth of the
recall
•Class I recalls generally to consumer/user depth via
press release
•Class II generally to retail depth; some to
consumer/user via press release
•Class III generally to retail depth when problem when
problem obvious to consumer
07/15/13 22
23. Communicating with the FDA
• Notify FDA District Recall Coordinator and provide information in a
timely manner
• Info needed by FDA includes:
– Product (identity, size and type of containers, brand names, lot numbers, whether
refrigerated/frozen/shelf stable)
– Codes
– Amount manufactured and amount distributed
– Number of and types of consignees
– Area of distribution
– Reason for recall
• Discuss recall strategy with FDA (including disposition of recalled
product)
• Let FDA review text of phone notifications, written recall notifications,
press releases (follow models provided in FDA guidance)
• Provide FDA with consignee list
• Provide actual labels or clear photos of labels07/15/13 23
24. Communicating with Consignees
•Be brief and to the point
•Identify clearly the product, size, lot number(s), code(s) or serial
number(s) and any other pertinent descriptive information to
enable accurate and immediate identification of the product
•Explain concisely the reason for the recall and the hazard
involved, if any
•Provide specific instructions on what should be done with
respect to the recalled products
•Provide a ready means for the recipient of the communication to
report to the recalling firm whether it has any of the product
•Provide sub-recall instructions (if necessary)
•Re-contact non-responders and conduct effectiveness checks
07/15/13 24
25. Press release
•Follow FDA models as closely as possible –“fill in the
blanks”
•Do not change hazard statement –don’t take out “life
threatening”
•Issue press release to Associated Press
•Provide FDA with confirmation that press release was
sent to AP
•FDA will issue if firm will not or if firm’s is
inadequate
07/15/13 25
27. drugsrecall in 2013
Date Brand Name Product Description Reason/ Problem Company
07/03/2013 Estarylla
Estarylla
(norgestimate and
ethinyl estradiol)
tablets
Report of a
placebo tablet
present in a row
of active tablets
Sandoz
06/30/2013 Nexus, APP
Benztropine
Mesylate Injection
Glass particles Fresenius Kabi USA
06/19/2013 Rugby
Enteric Coated
Aspirin Tablets,81
mg
May Contain
Acetaminophen
500 mg tablets
Advance
Pharmaceutical Inc.
06/13/2013
Sagent Pharmaceuticals, Inc.
Vecuronium
Bromide for
Injection
Due to elevated
impurity levels
Sagent
Pharmaceuticals, Inc.
06/11/2013 Bethel Weight Loss Pills
Contains
Undeclared Drug
Ingredient
Bethel Nutritional
Consulting, Inc.
06/10/2013 ZyGenerics
Warfarin 2 mg
Tablets
Oversized tablet
Zydus
Pharmaceuticals
USA Inc.
06/07/2013
Sagent Pharmaceuticals,
Inc.
Vecuronium
Bromide for
Injection
Due to elevated
impurity levels
Sagent
Pharmaceuticals, Inc.
07/15/13 27http://www.fda.gov/Safety/Recalls/default.htmhttp://www.fda.gov/Safety/Recalls/default.htm
28. 07/15/13 28
Date Brand name Product
Description
Problem/Reason Company
05/29/2013
Lowlite, Olympia
Pharmacy
All Sterile Products
Potential for non-
sterility
Lowlite Investments,
Olympia Pharmacy
05/28/2013
Main Street Family
Pharmacy
All Sterile Products
Potential for non-
sterility
Main Street Family
Pharmacy, LLC
05/25/2013 Fresenius Kabi USA
Magnesium Sulfate
Injection USP
Glass Particles Fresenius Kabi USA
05/21/2013
JaDera, Xiyouji
Qingzhi
Weight loss
supplement
Unapproved New
Drug
Dolphin Intertrade
Corp
05/20/2013 Sandoz
Methotrexate
Sodium, USP, 25
mg/mL, 40 mL vial
injectable vials
Particulate
material in vials
Sandoz US
05/15/2013 Pentec Health
In-date nutritional
prescriptions for
renal patients
Lack of sterility
assurance
Pentec Health
05/10/2013 Hospira
Piperacillin and
Tazobactam for
Injection
Precipitation/Cryst
allization in IV
bag
Apotex Corp.
http://www.fda.gov/Safety/Recalls/default.htm