Product recall

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Definition
Recall is the removal of pharmaceutical product
from the market for the reasons relating to
deficiencies in the quality ,safety or efficacy of that
product.

Recall may be conducted on the basis of

A Industrial's own initiative
By regularly authority request(eg TFDA)

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 Reasons of product recall
Serious reports of adverse drug reactions not
included in the package insert.
 Unexpected frequency of adverse reaction stated
in the package insert.
Incorrect labeling of a product.
Incorrect product formulation.
Result of ongoing stability studies.

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 Reasons of product recall

Chemical contamination.
Cross contamination.
Microbial contamination
Lack of control of foreign bodies ( exmple
glass )
Packaging problems

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 Example drugs recall include .
in 2019
Indusrty name:
Lupin Pharmaceuticals(uk).
Product :Ceftriaxone for Injection,
USP
Reason for recall:
Due to products contain visual grey
particulate matter in reconstituted
vial.

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Example drugs recall include .

In 1982
Brand name : Tylenol Extra
Strength
Product description,
Paracetamol capsule
Recall reason : contamination
with potassium cyanide

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Example of the recall letter
(from pharmaceutical industry)

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Recall Classifications
Classified by degree of risk of injury to the public,

Class I:
  Dangerous or defective products that could cause serious
health problems or death.
Examples include:
Chemical contamination with serious medical consequences
Microbial contamination of sterile inject able or ophthalmic
product
Wrong active ingredient in a multi component product with
serious medical consequences
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Recall Classifications
Class II:
Issued where there is no immediate danger of
death or other serious injury linked to the
product .but there is risk of injury or death.
Example;
Mislabelling (for example,wrong or missing text or
figures
Missing or incorrect safety information in leaflets
or insert

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Recall Classifications
Class III:
Products that are unlikely to cause any adverse
health reaction, but that violate TFDA labeling or
manufacturing laws.
Examples include:
 faulty packaging such as wrong or missing batch
number or expiry date
Faulty closure not resulting in any medical
consequences

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PRINCIPLES OF PRODUCT RECALL

1. There should be a system to recall from the

market, immediately and effectively, products
known or suspected to be defective.

2. The authorized person should be responsible for

the execution and coordination of recalls, he or
she should have sufficient staff to handle all
aspects of the recalls with the appropriate degree
of urgency.

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PRINCIPLES OF PRODUCT
RECALL
3. There should be established written procedures,
which are regularly reviewed and updated, for
the organization of any recall activity. Recall
operations should be capable of being initiated
promptly down to the required level in the
distribution chain.

4. An instruction should be included in the written

procedures to store recalled products in a secure
segregated area while their fate is decided.

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PRINCIPLES OF PRODUCT
RECALL
5. All competent authorities of all countries to which
a given product has been distributed should be
promptly informed of any intention to recall the
product because it is or suspected of being
defective.

6. The distribution records should be readily available

to the authorized person, and they should contain
sufficient information on wholesalers and directly
supplied customers to permit an effective recall.

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PRINCIPLES OF PRODUCT
RECALL
7. The progress of the recall process should be
monitored and recorded. Records should include
the disposition of the product. A final report
should be issued, including reconciliation
between the delivered and recovered quantities
of the product.

8. The effectiveness of the arrangements for recalls

should be tested and evaluated from time to
time.

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