drug recall defining and the stages of drug recall procedure.

1. Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF PHARMACEUTICAL
SCIENCES AND RESEARCH, ADOOR, KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY ASSURANCE

2. WHAT IS DRUG RECALL?
A process for withdrawing or removing a
pharmaceutical product from the pharmaceutical
distribution chain because of defects in the product,
complaints of serious adverse reactions to the product or
concerns that the product is counterfeit. The recall might
be initiated by the manufacturer, wholesale dealer license
holder or the Department of Health.

3. OBJECTIVES OF A DRUG RECALL
› To stop the distribution and sale of the affected product.
› Effectively notify management, customers and
regulatory authority.
› Efficiently remove the affected product from the market
place, warehouse or distribution areas.
› Dispose and conduct a root cause analysis and report the
effectiveness and outcome of the recall.
› Implement a corrective action plan to prevent another
recall.

4. According to Central Drugs Standard Control
Organisation (CDSCO), quality defects may include,
› Drugs of not standard quality
› Spurious or adulterated drugs
› Drugs manufactured under cancelled or suspended
license.
› Drugs manufactured despite being prohibited under
the provisions of the Drugs & Cosmetics Act

5. REASONS FOR DRUG RECALL
› Potentially dangerous or serious product quality issues have
come to light through complaints.
› Mandatory regulations have been violated and come to the
notice of regulatory agency.
› Labelling errors and incorrect outer packing.
› Lack of assurance of sterility and drug stability.
› Misbranded drug
› Lack of efficacy, failing dissolution test requirements,
microbial contamination in products
› New information comes into light after distribution of
product indicates it is unsafe or ineffective or dangerous.5

6. CLASSIFICATION OF DRUG RECALL
The CDSCO classifies Recalls into three categories:-
CLASS I – is the situation in which there is reasonable
probability that the use of a defective product will cause serious
adverse health consequences or death.
› Recalls under this class must be executed to the level of
distributor/wholesaler, retailer and consumer.
› Public announcements shall be made using print and electronic
media
› Timeline for recall ranges from within 24-72hours
› Stopping the sales or distribution must be done within – 24hours
› Physical recall must be completed within – 72hours.
› E.g. – wrong active ingredient, wrong strength.

7. CLASS II – is the situation in which use of defective product may
cause temporary adverse health consequences
› Probability of serious ADR is remote.
› Recall is limited at level of distributor/ wholesaler.
› Time limit for recall is within – 10 days. E.g.- mislabelling.
CLASS III – is the situation in which the use of defective product
is not likely to cause any adverse health consequences.
› Recall is executed until the wholesaler level.
› Time limit – 30days. E.g. – faulty closure, wrong expiry date.
Banned drugs for which license is cancelled or suspended, if
found to be in the market, shall have to be recalled, - being
treated as CLASS I

8. TYPES OF DRUG RECALL
Product recall may be of two types:-
A) Voluntary Recall
› refers to situations when manufacturer decides on
their own initiative to recall products where the safety,
efficacy and quality of batch is in question
› E.g 1. – an in-house reveals a failure that can cause
adverse effect on the quality of a batch of products that
has been distributed.
› E.g 2. – market complaints investigation show that the
entire batch is defective.
› E.g 3. – visual inspection of retained show evidence of
deterioration that has an impact on product quality.

9. B) Statutory Recall
› refers to recalls mandated by drug regulatory bodies
at Central or State levels for one of the reasons
› E.g 1. – product violates the law – not of standard
quality.
› E.g 2. – formulation contains banned drugs.
› E.g 3. – labelling of product or promotional material
violates the law.
› E.g 4. – product claims to treat diseases mentioned in
Schedule J (claims to cure a disease that no drug can)

10. PRODUCT RECALL SYSTEM
› Every company is required to have a product recall system
in place to effect a prompt and effective recall in case of
serious complaints regarding defective products.
› As per cGMP guidelines, product recall activities must be
coordinated and executed by an authorized person who is
independent of the marketing and sales function of the
company.
› The recall approving authority is generally the Head of the
Company (President/Proprietor/Managing Director).
› Recall strategy must be prepared which is a planned specific
course of action to be taken in conducting a specific recall.

11. Recall strategy details must include information regarding:
› Authorized person who will initiate the recall.
› Nature of communication that will be used to initiate recall
(telephone, email, letters etc.).
› Depth of the recall to be instituted (recall from
distributor/wholesaler/hospital/ retailer/general public).
› Manner of receiving, segregating and secure storage of the
recalled product.
› Satisfying reports to be prepared, at what frequency.
› Verification of success of recall and report submission to
regulatory authorities.
› Steps to be taken to avoid re-occurrence of the same issue
with the product.
› Dealing with recalled product – reworking or destruction as
may be appropriate

12. PRODUCT RECALL TEAM
› A recall coordinator is to be appointed and members of a
recall team identified from the various functional areas.
› All members must ensure that all procedures are carried out
effectively and efficiently. The team should receive
appropriate training.
› Recall management team list shall be updated at least four
times a year.
› Chief executive officer – decision making, media
communication.
› Quality assurance manager – quality or technical
advisory, complaint investigation

13. › For potentially violative product that may lead to a
Class I or II recall, an inspection should be made to
determine the root causes of the problems.
› The suspected problem is discussed with the
management and reviewed.
› Review batch records, or other types of records for
violative lots.
› Determine what actions the firm has taken or plans to
take.
PRODUCT RECALL PROCEDURE

14. If the firm has decided to recall,
› Management should obtain the FDA’s district review
of recall and any press releases before they are issued
to prevent misunderstandings between the firm, its
customers, and FDA.
› Obtain an official sample of the recalled product, a
complete distribution list of all shipments of the
suspect lot, specimens pr copies of all labels.
› Obtain complete copies of all recall communications
issued or planned including phone or text
conversations, and submit them to districts recall
coordinator.

15. STAGES OF PRODUCT RECALL
1. Recall alert
2. Recommendation for recall number
3. Recall product
4. Code
5. Recalling firm/ manufacturer
6. Reasons for recall
7. Volume of product in commerce
8. Distribution pattern
9. Firms recall strategy
10. Firm official
11. Audit program
12. Monitoring recalls
13. Termination of recall
14. Close out inspection

16. 1. Recall alert:- a 24hour alert is given for the product
recall.
2. Recommendation for recall number - a
memorandum should be prepared as soon as the recall
number is available
3. Recall product – its name, type, strength, size, form,
route of administration, brief description of the
product whether it is OTC or prescription based.
4. Code – list of all lot/serial number, product number,
manufacturer number which appears on the product
label.
5. Recalling firm – provide complete name & address of
the recalling firm & identify the type of firm i.e.,
manufacturer, importer, etc.

17. 6. Reasons for recall – a detailed information based on
the analytical findings in qualitative or quantitative
terms, inspectional evidences, or complaints, injuries
that prove the product is defective.
7. Volume of Product in Commerce – total product
distributed at all levels.
8. Distribution pattern – report the areas of distribution
of products to the local areas of all levels, foreign
countries, government military agencies.
9. Firms recall strategy – describes the firm’s planned
recall strategy. Includes the date of initiation of recall.

18. 10. Firm Official – report the name, title, location, and
telephone number of the firm official to be contacted
concerning the recall.
11. Audit program – report appropriate action taken &
also provide details of any publicity issued or planned
by the firm, state or local govt.
12. Monitoring recalls –
a. Re-inspect the firm between and termination of recall
to monitor its progress
b. A recall audit check is a personal visit or phone call to
consignee from a recalling firm in the chain of
distribution.

19. c. Conducting the check –
› Details of the recall
› Recall strategy
› Amount of product recalled till date
› Visit storage sites of the recalled product, check shelf
stock to ensure all recalled product has been identified,
removed from areas and properly quarantined.
› If injury or complaint is reported, furnish the
corrective actions taken
› Amount of product destroyed, and method of
destruction.
d. Reporting of the audit checking.

20. 13. Termination of recall - a recall will be terminated if
efforts have been made to remove or correct the
violative product in accordance with the recall
strategy. Written notification that a recall is terminated
will be issued by the authority to the recalling firm.
14. Close out inspection – a limited inspection made to
verify the termination of recall by the recalling firm.
During the closeout inspection, witness destruction or
reconditioning of the recalled product is done.
If unable to witness the destruction, a written
documentation from firm should be obtained.