Product recall overview

1. PRODUCT
RECALL
Republic of the Philippines
Department of Health
Food and Drug Administration

2. Republic of the Philippines
Department of Health
Food and Drug Administration
What is
PRODUCT
RECALL?

3. A recall is when a product
is removed from the
market… because it is
either defective or
potentially harmful.
– US FDA
Permanent removal of therapeutic
goods from supply or use for
reasons relating to deficiencies in
the quality, safety or efficacy of
goods. – Therapeutic Goods
Administration, Australia

4. 4
There should be a system
to recall from the
market, promptly and
effectively, products
known or suspected to be
defective. – WHO
In order to protect public health… necessary to
implement urgent measures such as the recall of
one or more defective batch(es) of a medicinal
product from the market.
– European Medicines Agency (EMA)

5. Republic of the Philippines
Department of Health
Food and Drug Administration
BUREAU CIRCULAR
NO. 8, S. 2001
Guidelines to be Observed
on the Implementation of
Product Recall System

6. B.C. No. 8,
s. 2001
 Actions taken to remove a product
from the market
 Initiated by FDA or voluntarily done
by company

7. B.C. No. 8, s. 2001
 Encompasses also labeling and/or
promotional literature
 Misbranded products still in violation of the
law are included
 Health risks evaluated by a Product
Recall Committee

8. HEALTH HAZARD EVALUATION
Factors to be considered:
• Assessment of the likelihood of
occurrence of the hazard
• Assessment of the consequences of
occurrence of hazard

9. HEALTH HAZARD EVALUATION
Factors to be considered:
• Assessment of the degree of seriousness
of the health hazard
• Whether any disease or injury has
already occurred

10. HEALTH HAZARD EVALUATION
Factors to be considered:
• Whether any existing condition(s) could
contribute to a clinical situation that could
expose human or animal health hazard
• Presents risk of gross deception to the
public

11. RECALL CLASSIFICATION
Class 1 Recall
Situation in which there is a
reasonable probability that the use or
exposure to the product will cause
serious adverse health consequences
or death

12. RECALL CLASSIFICATION
Class 2 Recall
Situation in which use or exposure to
the product may cause temporary or
medically reversible adverse health
consequences or where the probability
of serious adverse health consequences
is remote

13. RECALL CLASSIFICATION
Class 3 Recall
Situation in which use or exposure to
the product is not likely to cause
adverse health consequences

14. 14
WHO WILL
INITIATE
THE RECALL?

15. A. FIRM INITIATED RECALL
 Informs FDA of the voluntary recall
 The Marketing Authorization Holder
(MAH) is required to communicate with
its consignees and inform them of the
intended product/s for recall

16. A. FIRM INITIATED RECALL
 You must know the ff.:
1. Identity of the product
 Generic Name, Brand Name
 Dosage Form and Strength
 Registration No.
 Batch or Lot No.
 Date of Manufacture and Expiration
2. Reason for the removal

17. B. FDA ORDERED RECALL
 The Director General of the FDA may
order a firm to initiate a recall upon the
recommendation of Product Recall
Committee when the following
determinations has been made:
 Distributed product presents a safety
risk of illness or injury or gross consumer
deception

18. B. FDA ORDERED RECALL
 A firm has not initiated a recall of the
product
 An agency action is necessary or
advisable to protect the public health
and welfare

19. FDA ORDERED RECALL
 Firm shall be notified to order a recall,
and of the need to begin immediately a
recall of the product
 Notification will specify the ff.:
 Violation
 Health Hazard classification (Class I, II, or
III)
 Recall strategy
 Any other instructions appropriate

20. GENERAL PROCEDURE FOR
PRODUCT RECALL
20
MAH
• Notify FDA of a product recall
• State the full detail of the reason for conducting the recall (e.g. reason, batch/es
impacted, circumstances, etc.)
PRC
• Receipt of case report/communication from Marketing Authorization Holder
(MAH)
• Assess the health hazard
• Submit a written recommendation to the Director General for the issuance of recall
order
• Public Health Alert will be issued within 24 hours for cases that have been
determined as Class I or Class II Recall

21. GENERAL PROCEDURE FOR
PRODUCT RECALL
21
RFO
• In-depth inspection of responsible
establishment/production facilities where the
violation occurred
• Refer action done back to Product Recall Committee
(PRC)
RFO or
Legal or PRC
• In case the firm refuses to conduct the recall,
regulatory action will be pursued
• Upon determination that the recall process has been
completed, a written notification of acknowledged
completion will be given to the recalling firm

22. RECALL STRATEGY
The following elements shall be included in a
recall strategy:
1. Depth of Recall (distributor level, retailer
level)
2. Effectiveness Checks
 In developing a recall strategy, the duration to
complete the recall operation should be
considered.

23. RECALL STRATEGY
Duration of recall operation:
 Class I Recall – Seven (7) days
 Class II Recall – Fifteen (15) days
 Class III Recall – Thirty (30) days

24. RECALL STRATEGY
Duration of recall operation:
PROPOSAL
Class I Fourteen (14) days
Class II Twenty (20) days
Class III Thirty (30) days

25. PUBLIC HEALTH ALERT
 Issued within twenty-four (24) hours
after the duly signed PRO is received
by the representative of the MAH
 Purpose of alerting concerned
populations to serious health hazards

26. PUBLIC HEALTH ALERTHOW TO VIEW ADVISORIES?

27. UPDATED LIST OF ADVISORIES
FOR DRUG PRODUCTS AS OF 24
JUNE 2015

28. UPDATED LIST OF ADVISORIES
FOR DRUG PRODUCTS AS OF 24
JUNE 2015

29. • Product Information
– Generic name and/or Brand name
– Dosage form
– Dosage strength
– Registration No.
• Batch No. or Lot No. specified
• Importer or Distributor
• Manufacturer
SALIENT POINTS TO LOOK FOR
IN ADVISORIES

30. 30
WHAT TO
CHECK IN
ADVISORIES?

31. Product Information?
Generic name
Brand name
Dosage form
Dosage strength
Registration No.
Batch No. or Lot No.?
Importer or Distributor?
Manufacturer?

32. Product Information?
Generic name
Brand name
Dosage form
Dosage strength
Registration No.
Batch No. or Lot No.?
Importer or Distributor?
Manufacturer?

33. Product Information?
Generic name
Brand name
Dosage form
Dosage strength
Registration No.
Batch No. or Lot No.?
Importer or Distributor?
Manufacturer?

34. Product Information?
Generic name
Brand name
Dosage form
Dosage strength
Registration No.
Batch No. or Lot No.?
Importer or Distributor?
Manufacturer?
Principal Product ?
e.g. DRP-282
Identical Product?
e.g. DRP-282-02
For more information:
Refer to
Administrative
Order No. 2005-0031
FDA Circular No.
2015-001

35. TERMINATION
OF PRODUCT
RECALL
ORDER

36. Seizure, multiple seizures or other
court action shall be undertaken by
FDA
REFUSAL OR
FAILURE OF FIRM
TO CONDUCT
PRODUCT RECALL

37. DISPOSITION OF RECALLED
PRODUCTS
 MAH will coordinate with FDA
 If the products are to be destroyed, the
destruction should be witnessed by a
FDA representative

38. • Proactive cooperation with the distributor
or MAH… Follow-up at all times
• Routine checking of advisories from the
FDA website
• Upon seeing the advisory, the stocks of the
drug product meant for recall must be
removed from the selling area within 24
hours and stored in a secured area
WHAT IS REQUIRED FROM
YOUR END?

39. • Must observe the recall duration:
► Return immediately the stocks of recalled
product/s to the distributor
► Proper documents must show the actual
quantity returned
• Product recalls must be treated ALWAYS AS
URGENT!
WHAT IS REQUIRED FROM
YOUR END?

40. “Drug safety is
everybody’s
concern”

41. THANK
YOU