handling of pharmaceutical product recall

Presented by
Deepak S Ghogare
M.Pharm F.Y. QAT
Under the guidance
Miss. Anuja S Khidse
Dept. of pharmaceutical chemistry
Thursday, March 1, 2018

What we will study in this chapter ?
What is pharmaceutical product recall ?
What are the reasons of pharmaceutical product recall ?
What is the process involved in pharmaceutical product recall ?
What to Do if Drug You're Taking Is Recalled ?

What is a Pharmaceutical product recall?
Recall means a firm's removal or correction of a marketed
product 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.
As per USFDA ,

FDA proposed a rule in January of 2013 that would
require food manufacturers to maintain a recall plan as
part of the preventive controls requirements set forth in
section 103 of the FSMA(food safety modernization act).
FDA’s current regulations at 21 C.F.R. §§ 7.40-7.59
provide valuable guidance for manufacturers of food and
other FDA-regulated products.
Regulatory Requirement

21CFR Part 7, Subparts A and C - Recalls - General guidelines
21CFR Part 107, Subpart E -Mandatory recall of Infant formula
21 CFR Part 1270 - Human Tissue
PHS Act - 42 U.S.C. 26 - Mandatory recall of biological
products
21 CFR Part 806 - Medical Device Corrections and Removals
FD&C Act, 518(e) - Mandatory Device Recalls
Regulatory Requirement:

Figure –USFDA Recalls in
2006-2015

Reasons of pharmaceutical product recall
1. Super or sub-potent formulations
One example was Actavis, which was forced to recall its digoxin
tablets Digitek in 2008 because the pills were thought to have been
manufactured to a double thickness.
2. Particulate contamination
Number two in our top five is contamination with particulate
matter, a group which we have combined to include all cases
where the contamination has come from inorganic materials
such as glass, silicone and stainless steel.

3. Is poorly manufactured
Manufacturing defects related to a product’s quality, purity, and
potency may be to blame for a drug recall.
4. Is mislabeled or packaged poorly:
Sometimes a medicine is recalled because of confusing dosing
instructions or a problem with the dosing tool provided with the
drug.

Thursday, March 1, 2018Thursday, March 1, 2018
5. Is not what it says:
For example, you may think you are taking a pain reliever
based on the package material, when in fact what is inside the
box is something else.
6. Is a health hazard:
Unfortunately, some health risks associated with certain
medications are not realized until after they become widely
used.

 Stop the distribution and sale of the affected product.
 Effectively notify management, customer and regulatory authority.
 Efficiently remove the affected product from the marketplace, warehouse
and distribution area.
 Dispose and conduct a root cause analysis and report the effectiveness of
the recalls.
 Impliment a corrective action plan to prevent another recall.
OBJECTIVE OF RECALL PLAN

1. Receipt of Pharmaceutical Product Problem Report
to the Department of Health
Recall Stage :
2. Initiation of a Recall
3. Assessment of Recall
4. Recall
5. Progress of Recall and
Report
6. Evaluation of the Recall

Thursday, March 1, 2018Thursday, March 1, 2018
Who conducts Recall
As per the USFDA 21CFR 7.45
Food and Drug Administration-requested recall.
As per the USFDA 21CFR 7.46
Firm-initiated recall.
Consumer may also request for
recall

Drug recalls are classified in the USFDA 21CFR7
& European Medicines Agency (EMA):
1. Class I recalls
2. Class II recalls
3. Class III recalls

Class I Recalls
Consumption of the drug will lead to adverse health effects or
death.
Recall will be required to be initiated within 72 hours after
the receipt of information.
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.

Class II Recalls
Medically reversible health effects. medically reversible health
effects.
Class II will be required to occur within 10 days of the receipt of
information.
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.

Class III Recalls
Adverse health effects are not likely to occur when consuming
the drug.
Class III recalls will be required to occur within 30 days of the
receipt of information.
Sanofi has recalled four batches of Combiflam after India’s
Central Drugs Standard Control Organisation (CDSCO) found it
was not meeting specifications for disintegration, Reuters
reports.

Market withdrawals
Market withdrawals occur when a product has a minor violation that
does not require FDA legal action.
Medical device safety alerts
Issued in situation where a medical device may present in unreasonable
safety risks associated with using a product.

Recall policy
 Recall is an effective method of removing or correcting consumer
product that are violation of law administered by the FDA.
 Recall may be undertaken voluntarily and at any time by manufactures
and distributors Or at the request of FDA.
 Recall is generally more
appropriate and affords better
protection for consumer.

Recall strategy:
Depth of recall
1.Consumer level which may vary with product,
including any intermediate wholesale or retail level
2. Retail level including any intermediate wholesale level
3. Wholesale level
As per 21CFR7.42 recall strategy that takes into account the
following element:

Public Warning :
The purpose of a public warning is to alert thepublic that a
product being recalled presents a serious hazard to health
1.General public warning:
General news media, either national or local as appropriate
2.Using news media:
Specialized news media, e.g., professional or trade press

Effectiveness check:
Level A- 100 percent of the total number of
consignees to be contacted.
Level B- Greater that 10 percent and less than 100
percent of the total consignees;
Level C- 10 percent of the total number of
consignees to be contacted;
Level D- 2 percent of the total number of
consignees to be contacted .
Level E- No effectiveness checks.

Termination of a recall
As per 21CFR 7.55,
 Request termination of its recall when all reasonable efforts
have been made to remove or correct the product in
accordance with the recall strategy.
 Request termination of its recall by submitting a written
request to the appropriate Food and Drug Administration
district office stating that
the recall is effective.

Here are some tips to keep in mind
when a drug is recalled:
2.Get educated:
To find out more about drug recalls, visit the FDA web site
1.Don't panic:
Remember that most drug recalls are for minor issues.
3.Play it safe:
Any issue about packing quality smell labeling reported to FDA
4.Safely discard recalled drugs:
5.Call your doctor:

Conclusion:
This part also provides guidance for manufacturers and
distributors to follow with respect to their voluntary removal
or correction of marketed violetive
products.
This part is promulgated to clarify and explain the regulatory
practices and procedures of the FDA enhance public
understanding, improve consumer protection,and assure
uniform and consistent application of practices and
procedures throughout the agency.

REFERENCE:
1. Guidelines of USFDA 21CFR7 for drug recall
2. Pharmaceutical product recall : lesion earned
volume 6 issue 1 spring 2014
3. Complaint handling in pharmaceutical company by
G.K. Braga
4. Https://en.wikipedia.org/wiki/Drug_recall
5. www.google.com
6. www.photobukket.com
7. www.slideshare.com

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