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  • TABLET;ORAL - 150MG
  • TABLET;ORAL - 300MG
  • TABLET;ORAL - 75MG
  • TABLET;ORAL - 12.5MG;150MG
  • TABLET;ORAL - 12.5MG;300MG
  • TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.business-standard.com/article/news-cm/iol-chemicals-secures-patent-for-invention-related-to-preparation-of-sartan-drugs-122112400926_1.html

BUSINESS-STANDARD
27 Nov 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-3-2022-1659944441.pdf

FDA
03 Aug 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-11-2021-1636538960.pdf

FDA
10 Nov 2021

https://www.hsa.gov.sg/announcements/product-recall/recall-of-six-batches-of-aprovel-film-coated-tablet-150mg-coaprovel-film-coated-tablet-150-12.5mg-and-coaprovel-film-coated-tablet-300-12.5mg

HSA
01 Nov 2021

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan

FDA
15 Oct 2021

https://www.newswire.ca/news-releases/advisory-multiple-lots-of-irbesartan-losartan-and-valsartan-drugs-recalled-due-to-azido-impurity-824128492.html

NEWSWIRE
17 Sep 2021

https://www.fiercepharma.com/manufacturing/sanofi-eyeing-impurity-concerns-abroad-pulls-trio-hypertension-meds-korea-could-next

F. Kansteiner FIERCEPHARMA
11 Aug 2021

https://www.gov.uk/government/news/mhra-recalls-contaminated-irbesartan-batches-as-precautionary-measure#:~:text=The%20MHRA%20today%20has%20issued,risk%20of%20cancer%20over%20time.

MHRA
09 Aug 2021

https://www.pharmacompass.com/pdf/news/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21a19-1628667463.pdf

GOV.UK
09 Aug 2021

https://www.firstwordpharma.com/node/1838903?tsid=4

FIRSTWORDPHARMA
18 Jun 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=139364&sid=2

PHARMABIZ
17 Jun 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75715a-eng.php

HEALTH CANADA
15 Jun 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75851r-eng.php

HEALTH CANADA
14 Jun 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75849r-eng.php

HEALTH CANADA
14 Jun 2021

https://www.pharmacompass.com/pdf/news/sandoz-canada-inc-issues-recall-of-sandoz-irbesartan-product-1622524589.pdf

HEALTH CANADA
31 May 2021

https://www.pharmacompass.com/pdf/news/mint-pharmaceuticals-inc-issues-recall-of-mint-irbesartanhctz-product-1622524943.pdf

HEALTH CANADA
27 May 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75733r-eng.php

HEALTH CANADA
27 May 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75705r-eng.php

HEALTH CANADA
27 May 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75691r-eng.php

HEALTH CANADA
26 May 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75689r-eng.php

HEALTH CANADA
26 May 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75685r-eng.php

HEALTH CANADA
25 May 2021

https://www.fiercepharma.com/manufacturing/fda-warning-letter-tags-torrent-as-key-offender-production-tainted-blood-pressure

Eric Palmer FIERCE PHARMA
17 Oct 2019

https://www.biospace.com/article/6-major-drug-recalls-in-the-past-for-health-concerns/?s=95

Charlie Harper BIOSPACE
17 Oct 2019

https://www.reuters.com/article/us-fda-valsartan/fda-says-widening-probe-on-generic-drug-impurities-idUSKCN1VI1RH

Michael Erman REUTERS
29 Aug 2019

https://www.fiercepharma.com/manufacturing/aurobindo-gets-warning-letter-over-valsartan-recall-mess

Eric Palmer FIERCE PHARMA
03 Jul 2019

https://www.raps.org/news-and-articles/news-articles/2019/7/fda-sends-warning-letters-to-aurobindo-api-repack?feed=Regulatory-Focus

Michael Mezher RAPS
03 Jul 2019

https://www.raps.org/news-and-articles/news-articles/2019/5/fda-483s-pile-up-in-crackdown-on-sartan-manufactur

Ana Mulero RAPS
18 May 2019

https://www.pharmacompass.com/pdf/news/health-canada-issues-recall-of-auro-pharma-auro-irbesartan-hct-tablet-1556075291.pdf

HEALTH CANADA
18 Apr 2019

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/69328a-eng.php

HEALTH CANADA
18 Mar 2019

https://www.cnbc.com/2019/03/01/reuters-america-fda-finds-new-cancer-causing-impurity-in-blood-pressure-pills.html

Saumya S. Joseph CNBC
02 Mar 2019

https://www.tga.gov.au/alert/sartan-blood-pressure-medicines

TGA
26 Feb 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-6-2019-1549474146.pdf

FDA
06 Feb 2019

https://www.edqm.eu/en/news/update-edqm-review-cep-applications-sartan-substances-4-february-2019

EDQM
04 Feb 2019

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629796.htm

FDA
25 Jan 2019

https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm?utm_campaign=UPDATE%20on%20angiotensin%20II%20receptor%20blocker%20%28ARB%29%20recalls%3A%20Torrent%20further%20expands&utm_medium=email&utm_source=Eloqua

FDA
23 Jan 2019

https://www.taiwannews.com.tw/en/news/3620911

Ryan Drillsma TAIWAN NEWS
19 Jan 2019

https://www.pharmacompass.com/pdf/news/prinston-pharmaceutical-recalls-irbesartan-and-irbesartan-hctz-tablets-due-to-ndea-impurity-1547993542.pdf

FDA
19 Jan 2019

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM629626.pdf

FDA
19 Jan 2019

https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm?utm_campaign=UPDATE%20on%20angiotensin%20II%20receptor%20blocker%20%28ARB%29%20recalls%3A%20FDA%20alerts%20patients%20and%20health%20care&utm_medium=email&utm_source=Eloqua#interimlimits

FDA
19 Jan 2019

https://www.edqm.eu/en/news/update-review-cep-applications-sartans-18-january-2019

EDQM
18 Jan 2019

https://www.usatoday.com/story/news/health/2019/01/14/fda-zhejiang-huahai-hetero-labs-blood-pressure-drug-recall-cancer/2547858002/

Ken Alltucker USA TODAY
14 Jan 2019

https://www.raps.org/news-and-articles/news-articles/2019/1/eu-regulatory-roundup-uk-nhs-calls-for-changes-to?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2010%20January

Nick Paul Taylor RAPS
11 Jan 2019

https://www.dnaindia.com/business/report-a-wave-of-drug-recalls-hits-indian-pharma-firms-in-us-2705817

DNA INDIA
09 Jan 2019

https://assets.publishing.service.gov.uk/media/5c2df2fee5274a65a26f4b71/EL__19__A_01_Final.pdf

GOV UK
03 Jan 2019

https://www.gov.uk/government/news/irbesartan-blood-pressure-and-heart-medication-recalled-from-pharmacies-by-mhra

GOV UK
03 Jan 2019

https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm

FDA
21 Dec 2018

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM624627.pdf

FDA
20 Dec 2018

https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11192018103541

FDA
19 Dec 2018

https://www.ema.europa.eu/documents/referral/sartans-article-31-referral-timetable-procedure_en.pdf

EMA
18 Dec 2018

https://www.pharmacompass.com/pdf/news/fda-warns-api-manufacturer-involved-in-valsartan-recall-1544687855.pdf

FDA
12 Dec 2018
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