The document discusses a case study on the product recall of Saniderm hand sanitizer. It provides background on how drug recalls have increased in recent years. It then describes how the FDA investigated Saniderm hand sanitizer after receiving complaints, finding it contained toxic methanol instead of isopropyl alcohol. This led to a Class I recall in June 2020 and the FDA warning consumers not to use products from the manufacturer. The case study outlines the timeline of FDA announcements and concludes that the FDA remains vigilant in ensuring hand sanitizers are safe to use.

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
A Seminar as a part of curricular requirement
for I year M. Pharm I semester
Presented by
V.NABI RASOOL. (20L81S0401).
M.PHARM
Department of Pharmaceutical Quality Assurance.
Under the guidance/Mentorship of
Dr. P. Ramalingam., Ph.D.
Director- R&D Division,
Professor of pharmaceutical analysis
and medicinal chemistry
CASE STUDY
ON
PRODUCT RECALL OF SANIDERM (hand sanitizer)

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
S.NO CONTENT
1 Introduction
2 Recall classification
3 Types of Recall
4 Recall strategy
5 Timeline for effective Recall system
6 Overview of Recall system
7 Recall guideines
8 Case study
9 Conclusion
10 Reference
Content Table

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
DEFINITION: Drug product recall is a process to withdraw or remove the drugs
from distribution or market for which deficiencies are reported in quality,
efficacy or safety.
• The defective products related to quality include adulterated or spurious
drugs.
• Safety and efficacy related recalls include serious adverse reactions and
death.
• Recalls also include drugs prohibited under the laws and also those products
for which product licenses are suspended or cancelled.
Introduction

4. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
• BACKGROUND
 Prior to 1962, there was no mechanism in the countries to approve drugs
before they went to market.
 So, many danger drugs were reached into the marketplace which causes the
adverse affect to the public health and sometime death may be occur.
 But companies didn’t recall their drugs products due to huge money loss.

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5
 There has been an increasing trend in the number of
prescription and over-the-counter drug recalls over the last 4
years.
 In 2009, the Food and Drug Administration (FDA) reported
1,742 drug recalls representing a increase over the 426 recalls
reported in 2008 and greater than 1,000 of the implicated
medications were from the same drug repackaging firm.
 Now drug recalls are still increased of about 50% between 2008
and until now.

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6
RECALL CLASSIFICATION
Is classified by regulatory
authorities to a particular
product recall indicating
relative degree of
healthhazard.
Class I is a situation in which there
is a reasonable probability that the
use of, or exposure to a defective
product will cause serious adverse
health consequences or death and as
well as banned under 26A of Drugs
and Cosmetics Act 1940.
Class II is situation in which the
use of, or exposure to, a defective
product may cause temporary
adverse health consequences or
where the probability of serious
adverse health consequences is
remote.
Class III is a situation in which the
use of, or exposure to, a defective
product is not likely to cause any
adverse health consequences.

7. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
Types
of
Recall
cccccccccc
Voluntary
Recall
• Is triggered by manufacturer in
response to incident affecting the
quality, safety and efficacy of a
batch/product of drug.
Statutory
Recall.
• Is done in response to direction or
mandate of the Drug Regulatory
Authorities(Central/State) in
situations as violation of the laws such
as NSQ, banned drugs or violation
Rule 106 (Diseases under Schedule J).

8. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8
 Name, strength, pack size, batch/lot number and any means of identification of the recalled product.
 Total quantity of the product being recalled originally in possession of the company.
 Area of distribution of the product, and if exported, the company to where it was exported.
 List of customers to whom product was issued.
 The quantity of the recalled product still in their possession.
 Suggested action to be taken and its urgency.
 Indication of the health risk together with reasons.
Basic information required for recall

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K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9
• In formulating a recall strategy, the following should be taken
into consideration
 Result of health hazard evaluation
 Ease in identifying the product
 Extent to which the product deficiency is obvious to the
customer/user
 Continued availability of essential products (risk-benefit)
Recall strategy

10. RIPER
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K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
• Based on the category of the risks involved,
 a timeline of within 24 hours up to a maximum of 72 hours for
Class I recall
 maximum upto 10 days for Class II
 maximum upto 30 days is allowed for Class III
Timelines for effective recall system

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K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11

12. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
S.No Countries Regulatory Authorities
1. INDIA
Central Drug Standard
Control Organisation
(CDSCO)
2. UNITED STATES
Food and DrugAdministration
(FDA)
3. UNITED KINGDOM
Mediciens and Healthcare
Products Regulatory Agency
(MHRA)
4. AUSTRALIA
Australian Product Recall
Authority
Countries and their Regulatory Authority

13. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13
High Profile Global Drug Recalls
Company Product Therapeutic class Year
Novartis Excedrin and Nodoz Pain -Reliever 2012
Glaxo Avandia Anti-diabetic 2010
Pfizer Bextra Anti-inflammatory 2005
Merck Vioxx Anti-inflammatory 2004
Bayer Baycol Anti-cholesterol 2001
Major drugs product recall of history

14. RIPER
AUTONOMOUS
NAAC &
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SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
 Guidelines on Recall and Rapid Alert System for Drugs (including
Biologicals & Vaccines) published in 2012 is applicable to all quality
defective product reports and reported incidents of safety and efficacy
received for drugs vaccines and biological.
 This guideline is followed by licensees (manufacturers, importers,
stockists, distributors, retailers) for voluntary or statutory recalls.
 The procedure is also used by Drugs Control Authorities of Central/State
when urgent recall action is required to protect public or animal health.
 This guideline provides stepwise procedures to be followed in recall
strategy, recall evaluation at every level and achieve compliance within a
specified time frame.
Recall Guidelines

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
• On 1’st April 2020, Eskbiochem SA de CV company produced
Saniderm Advanced Hand sanitizer packaged in one liter plastic
bottles and labeled with “Made in Mexico”.
• Unfortunately, after using that product most of the customers raised
complaints on saniderm hand sanitizer
• Then, FDA started investigation on saniderm hand sanitizer and
finally noticed this sanitizer with presence of methanol
• On June 19 2020, FDA advised consumers not to use any hand sanitizer
manufactured by Eskbiochem SA de CV in Mexico, due to the presence of
methanol, a substance that can be toxic when absorbed through the skin
or ingested.
Product recall of saniderm (Hand sanitizer)

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
cccc

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17
• Alcohol based hand rub mostly contains ethanol, isopropyl alcohol,
n-propyl alcohol, or their combinations.
• But Eskbiochem company misused this preparations and substituted
isopropylalcohol with methanol which is toxic either by accidentlly
or ingested deliberately.
• Methanol is even more toxic after inhalation, oral or skin exposures and must
never be used in hand hygiene products.
• Although all persons used these products on their hands are at risk, young
children who accidently ingested these products and adolescents and adults who
drank these products as an alcohol substitute, are more at risk for methanol
poisoning.
Root cause

18. RIPER
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 19

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20
• FDA tested samples of Lavar Gel and Clean care No Germ, contains
81 percent (v/v) methanol and no ethyl alcohol.
• Clean Care No Germ (80% alcohol) contains 28 percent (v/v)
methanol.
• So all the hand santizer products which are manufactured from the
Eskbiochem company are banned by FDA and those products are
removed from the market.
• Substantial methanol exposure can result in nausea, vomiting,
headache, blurred vision, permanent blindness, seizures, coma,
permanent damage to nervous system or death.

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21
• 19/06/2020 ALERT- FDA advises consumers not to use hand
sanitizer products manufactured by Eskbiochem.
• 02/07/2020 PRESS RELEASE- FDA takes action to warn, protect
consumers from dangerous alcohol based hand santizers containing
methanol.
• 27/07/2020 Coronavirus(COVID-19) UPDATE- FDA Reiterates
warning about dangerous alcohol based hand sanitizers containing
methanol, Takes additional action on importing.
• 31/07/2020 UPDATE-FDA continues to find issues with certain hand
sanitizer products.
Timeline

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22
• 12/08/2020 UPDATE- FDA expands hand sanitizers warning to include 1-
propanol contamination.
• 24/08/2020 UPDATE- FDA provides testing method to assess the quality of
hand sanitizer products for impurities.
• 26/01/2021 PRESS RELEASE- Coronavirus(COVID-19)UPDATE- FDA takes
action to place all alcohol based sanitizers from Mexico on import alert to
help prevent entry of violative and potentially dangerous products into
U.S., protect U.S. consumers.
• 25/03/2021 UPDATE- FDA warns consumers not to use Durisin
antimicrobial solutions recalled hand sanitizer alcohol free due to
microbial contamination.

23. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 23
• Centers for Disease Control and Prevention recommended
consumers to use an alcohol based hand sanitizer that contains
atleast 60 percent ethanol.
• FDA remained vigilant and continued to take action when quality
issues arised with hand sanitizers.
• Additionally, FDA is also concerned with false and misleading claims
for hand sanitizers, for example that they can provide prolonged
protection such as 24 hours against viruses including COVID-19, since
there is no evidence to support these claims.
Conclusion

24. RIPER
AUTONOMOUS
NAAC &
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Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24

25. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25
• https://www.fda.gov/drugs/drug-safety-and-availability/fda-
advises-consumers-not-use-hand-sanitizer-products-manufactured-
eskbiochem
• https://www.fda.gov/drugs/drug-safety-and-availability/drug-
alerts-and-statements

26. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 26