2. Recall:
A recall is defined as the removal of a marketed
product because of design or production defects
that may compromise safety, efficacy and purity
of the product or because of government
regulation.
3. When are Drugs Recalled?
A recall occurs when a drug manufacturer or the
FDA decides that a pharmaceutical drug is not safe
and should be removed from the market.
Sometimes a recall is necessary because new
research shows that the drug is too dangerous for use
by consumers.
4. This could be because of any of the following:
1.The drug causes dangerous side effects.
2.The FDA has discovered a safer alternative to the drug.
3.Consumers use the drug improperly and that unauthorized
use causes serious injury or death.
4.Manufacturing error or contamination incident makes a
particular batch of the drug unsafe.
5. Defective based on stability study, market complaints.
5. Product Recall:
Product recalls are actions taken by a firm to
remove a product from the market.
Recalls may be conducted on the basis of:
By FDA requested recall
By a Firm's own initiative recall
6. The FDA recall class schedule uses "1" as the
most dangerous and "3" as the least dangerous.
The severity of the recall is less as the number
increases.
7. FDA requested recall:
The FDA is responsible for making sure that
products like drugs, vaccines, and medical
devices are safe and effective.
FDA informs the manufacturer that its product is
defective and suggests or requests that the
manufacturer recall the drug.
8. These recalls are often highly publicized in
newspapers and on radio and TV news broadcasts.
The FDA has no authority under the Federal Food,
Drug and Cosmetic Act to order a recall.
The FDA does have the authority to ask a company
to recall a particular product.
9. FDA has jurisdiction over food, drugs, cosmetics,
medical devices and other products and serves as
a monitor over product recalls.
In most cases, recalls are done voluntarily by the
manufacturer or the distributor of the product.
10. In some cases, a company will discover that one of
its products is defective and will recall it.
In others cases, the FDA will notify a company that
one of its products is defective and will suggest or
request a recall.
Usually, the company will comply; if it does not, the
FDA can seek a court order authorizing the Federal
Government to seize the product.
11. The FDA guidelines categorize all recalls into one of
three classes according to the level of hazard
involved.
Class I recalls are for dangerous or defective
products that predictably could cause serious health
problems or death.
Examples of products that could fall into this
category are a food found to contain toxin, a label
mix-up on a lifesaving drug, or a defective artificial
heart valve.
12. Class II recalls are for products that might cause
a temporary health problem, or pose only a slight
threat of a serious nature.
One example is a drug that is under- strength, but
that is not used to treat life-threatening situations.
13. Class III recalls are for products that are
unlikely to cause any adverse health reaction, but
that violates FDA regulations.
An example might be bottles of aspirin that
contains 90 tablets instead of the 100 stated on
the label.
14. FDA will check on a company's performance in
recalling the product:
For a Class I recall, for example, the FDA would
check to make sure that each defective product
has been recalled or reconditioned.
In contrast, for a Class II and class III recalls the
FDA may decide that it only needs to spot check to
make sure the product is off the market.
15. Firm's own initiative (choice) recall:
Firm's own initiative recall is also known as the
manufacturer initiates the recall. This is the most
common method of recall.
A Manufacturer initiates the recall for:
Class I recall: 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.
16. Class II recalls are for products that might cause a
temporary health problem, or pose only a slight threat of
a serious nature.
One example is a drug that is under- strength, but that is
not used to treat life-threatening situations.
17. Class III recalls are for products that are unlikely to
cause any adverse health reaction, but that violates FDA
regulations.
An example might be bottles of aspirin that contains 90
tablets instead of the 100 stated on the label.
18. Some Examples of drug recalls include:
McNeil Consumer Healthcare's April 2010 recall of
certain batches of over-the-counter children's drugs,
including liquid Tylenol, Motrin, and Zyrtec because of
possible contaminants.
The 2008 recall of Baxter Healthcare's anticoagulant
drug, heparin, because the FDA found contaminants in
the drug that caused severe injury and death in some
people.
19. When a manufacturer initiates a drug recall, it must notify
the FDA, submit progress reports on the recall, and follow
up to make sure the recall was successful.
The FDA publishes guidelines for manufacturers to follow
when recalling drugs.
These are found in Title 21 of the Code of Federal
Regulations, Part 7.
i.e 21 CFR Part 7
20. Notice of Recalls:
There are several ways that the manufacturer and the FDA
notify consumers about a recall.
1.Direct notification.
The drug manufacturer must notify its direct accounts
(such as wholesalers or chain drug stores) about the recall.
21. 2.Public notification.
The FDA maintains a list of drug and medical device recalls
on its website (www.fda.gov) called Recalls, Market
Withdrawals, & Safety Alerts.
3.Media coverage:
Often, if a drug recall affects many people, or the recalled
drug causes severe injury or death, the media will report
on the recall.
