The document presents a case study on the recall of Telmisartan tablets by Alembic Pharmaceuticals Inc. due to mislabeling. The recalled lot of Telmisartan 20mg tablets was found to actually contain 40mg tablets. This posed risks like low blood pressure and kidney or potassium issues for patients. The recall was initiated in the US in March 2021 after the mistake was identified. The case study analyzes the details of the recall according to US FDA guidelines and provides a QA summary on post-marketing monitoring importance to prevent such errors.

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
Seminar Presented by
RAVI SHANKAR .D. (20L81SO403)
I-M Pharmacy (Quality Assurance)
Under the guidance of
Dr. P. Ramalingam .,PhD
Director-R&D division,
Professor of Pharmaceutical Analysis & Medicinal Chemistry
President-IPA local branch ; Anantapuramu
CASE STUDY ON PRODUCT RECALL

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
INDEX:
 Case study
 Product Recall
 Glimpse of the Company
 Case study of Telmisartan Tablets Recall
 QA Summary
 Reference

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

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
Definition :
A case study is an up-hold, in-depth and detailed examination
of a particular case with in a real world context.
Benefits :
 Collect a great deal of information.
 Chance to collect information on rare or unusual cases.
 Allows to develop hypotheses that can be explored in experimental research.
Limitation :
 Hard to estimate the magnitude of a causal effect.

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
Types of Case Studies :
Type purpose
Illustrative case study To define the queries of how & why
Exploratory case study To explain the queries of how & why
Cumulative case study To aggregate info from several sites
collected at different times
Critical instance case study To answer the cause & effect queries

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

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7
Definition-
A company’s removal of a marketed product because of design /production
defects regarding safety, efficacy & purity of the product or because of government
regulation.
As per FDA-
Recall means a firm's removal or correction of a marketed product that the
FDA considers to be in violation of the laws it administers and against which the
agency would initiate legal action, e.g., seizure.
 Progress of recall is monitored and closed by head QA & QC.
 Company submits the Recall status report to FDA where the frequency of these
reports can be specified.

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
FDA Recall procedure:
 Head QA&QC will investigate the market complaints and then regarding
stability failures
To evaluate the risk associated and initiate product recall
 In case of directives from regulatory authorities ,product recall will be commenced
as per the directives i.e.,
Head QA&QC will decide the type of recall in consultation with recall committee

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12
Head QA&QC will communicate the decision of recall along with
product details to the director of operations/ distribution manager / contract giver /.
Recall procedure for domestic market:
Distribution manager will send a product recall circular with time frame
immediately to various concerned persons in distribution
to return all stocks of product & credit a note for the stocks returned.
 Instructed to stop further sales of the product of the said batch.
 In case of urgent recalls in addition to sending circulars, immediate contact with
concerned should be established by telephone, fax, email/ any other available
means.

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
Glimpse of the company:
An Indian MNC company @Alembic Chemical Works.
Founded - 1907
Headquarters - Vadodara, Gujarat
Founders - Prof. T.K.Gajjar
- Prof. Kotibhaskar
- Rajmitra Mr. B.D. Amin
Key people -Chirayu Amin, (Chairman)
-Pranav Amin (MD)
-Shaunak Amin (MD)

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
Products:

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
 1907 - Tinctures & Alcohols
 1940 - Cough syrups, Vitamins, Tonics, Sulphur drugs
 1967 - Vit-B12
 1971 - Erythromycin mfg (1st time in India)
 1972 - Althrocin (a brand of erythromycin)
 1997 - top selling brand in India
 2017- Oncology medicine
Awards and recognitions:
• In 2016, Forbes included Alembic Pharmaceuticals in ‘India’s Super 50
Companies 2016’ list.
• In 2015, Alembic Pharmaceuticals received Thomson Reuters Top 50 Indian
Innovators Award .

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

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
Drug product - Telmisartan Tablets,USP,20mg
Lot no : 190505005661
NDC no : 62332-087-30

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
Route cause of the problem -
 MISLABELLING
i.e., Telmisartan Tablets,USP,20mg
which actually contains Telmisartan Tablets,USP,40mg
 Recall type - class 1 - by FDA on April 7,2021
 Recall initiated date - March 17,2021
 Place of recall - US
(The tablets were manufactured by Alembic Pharmaceuticals Limited, Gujarat,
India, for Alembic Pharmaceuticals Inc. Bridgewater, NJ, and were distributed
throughout the United States.)

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
Risk statement :
Alembic Pharmaceuticals Inc. mentioned that patients who had a double dose of
Telmisartan tablets which are being recalled
would experience - low blood pressure
- worsening of kidney functioning
- elevation of potassium levels
 Till now , didn’t receive any reports of adverse events related to this recall.

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
Identification of wrong product :
as per the company norms
Parameter Recalled product Actual product
shape oval round
colour White – half white White – half white
Debossed with L203 L202

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
 As per Alembic Pharmaceuticals Inc. mention -
consumers having Telmisartan Tablets, USP, 20mg which is being recalled
“ should not discontinue the use until speaking with their pharmacist / health care
professional.”
 Consumers with any query regarding this recall can contact Alembic
Pharmaceuticals Inc. through
• phone : +19085525839
• e-mail : david.cobb@alembicusa@com

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
Any adverse reaction / quality
problem experienced with the use of this
product may be reported to -
FDA’s MedWatch Adverse Event Reporting
Program either online by regular mail / by
fax.
E-Mail: info-enwikimedia.org

24. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24
QA Summary:
 Along with the post manufacturing evaluation of a finished product it is also
required for the visual re-verification of the label over the container.
 It might be silly mistake of a marketed product but it would lead severe
threats regarding the product quality, public health as well as the reputation of the
respective company.

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
Reference :
1. Guidelines of USFDA 21CFR for drug recall
2. Complaint handling in pharmaceutical company by G.K. Braga
3. Drugs.com
4. Pharmaguideline.com/2011/18/product-recall-procedure.html
5. Researchgate.com
6. Alembicpharmaceuticals.com
7. Managedhealthcareconnect.com

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