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Information Update - Multiple Losartan-containing drugs voluntarily recalled because of potential for nitrosamine impurity

OTTAWA, March 9, 2019 /CNW/ -AHealth Canada is advising Canadians that multiple lots of Losartan-containing drugs are being voluntarily recalled by Teva Canada, Apotex Inc., Pharmascience Inc., and Pro Doc LimitAe because of the potential for a nitrosamine impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). NMBA is potentially a human carcinogen, which means that long-term exposure could increase the potential risk of cancer.Teva CanadaAis voluntarily recalling two lots of combination Losartan/hydrochlorothiazide (HCTZ) tablets after testing of one lot identified levels of NMBA above what is considered reasonably safe if the drug were taken over a lifetime. Apotex Inc., Pharmascience Inc., and Pro Doc LimitAe are voluntarily recalling multiple lots of Losartan-containing products as a precaution.AAThe Losartan active pharmaceutical ingredient (API) in all of the recalled products isAmanufactured by Hetero Labs Ltd. Unit 1, in India. These recalls represent all lots of drugs distributed in Canada that contain Losartan API manufactured at Hetero Labs Ltd. Unit 1. Losartan is an angiotensin receptor blocker (ARB) drug, also known as a "sartan." Sartans are a class of drugs used to treat patients with high blood pressure to help prevent heart attacks and stroke. They are also used in patients who have had heart failure or a recent heart attack. There have been multiple recalls of products containing another sartan, valsartan, in Canada and internationally since July 2018 because of nitrosamine impurities (see links below for more information). As with previous recalls involving nitrosamine impurities, Health Canada is advising that there is no immediate risk to patients taking these medications, since the potential risk of cancer is with long-term exposure to the impurities. Patients should not stop taking their medication unless advised to do so by their healthcare provider. There are alternative products currently available on the Canadian market.AHealth Canada continues to monitor the supply situation. Health CanadaAencourages Canadians to visit drugshortagescanada.ca for information on drug shortages and discontinuances. Patients with questions or concerns about any drug they are taking, including on what to do if that drug is not readily available, should speak to their healthcare professional.Canadians with questions about the recalls can contact:

Apotex Inc. via Stericyle Inc. by calling toll-free at 1-877-492-4795;



Pharmascience Inc. by calling toll-free at 1-800-340-9735;



Pro Doc LimitAe by calling toll-free at 1-800-361-8559, or by email at medinfo@prodoc.qc.ca; or



Teva Canada by calling toll-free at 1-800-268-4129, or by email at customer.service@tevacanada.com.

Health Canada encourages consumers to report any health product-relatedAside effectsAorAcomplaintsAto the Department.Affected products
The following products containing Losartan manufactured by Hetero Labs Ltd. Unit 1 are being recalled. Health Canada maintains a complete list of sartan drugs that have been recalled because of nitrosamine impurities on its website.A

Product name/Active Pharmaceutical Ingredient (API)



DIN



Strength



Lot



Expiry



APO-LOSARTAN



02379058



25 mg



NL1453



08/2019



APO-LOSARTAN



02379058



25 mg



NL1452



08/2019



APO-LOSARTAN



02353504



50 mg



NK1254



08/2019



APO-LOSARTAN



02353504



50 mg



NK1253



08/2019



APO-LOSARTAN



02353512



100 mg



NL1461



08/2019



APO-LOSARTAN



02353512



100 mg



NG2092



04/2019



APO-LOSARTAN



02353512



100 mg



NH5932



06/2019



APO-LOSARTAN



02353512



100 mg



NH5933



06/2019



APO-LOSARTAN



02353512



100 mg



NL1460



08/2019



APO-LOSARTAN



02353512



100 mg



NH5934



06/2019



APO-LOSARTAN/HCTZ



02371235



50/12.5 mg



NL1441



08/2019



APO-LOSARTAN/HCTZ



02371235



50/12.5 mg



NZ8848



05/2020



APO-LOSARTAN/HCTZ



02371235



50/12.5 mg



NL1445



08/2019



APO-LOSARTAN/HCTZ



02371235



50/12.5 mg



NZ8849



05/2020



APO-LOSARTAN/HCTZ



02371235



50/12.5 mg



NZ8860



05/2020



APO-LOSARTAN/HCTZ



02371243



100/12.5 mg



NG2087



04/2019



APO-LOSARTAN/HCTZ



02371243



100/12.5 mg



NL1421



10/2019



APO-LOSARTAN/HCTZ



02371243



100/12.5 mg



NG2086



04/2019



APO-LOSARTAN/HCTZ



02371243



100/12.5 mg



NL1422



10/2019



APO-LOSARTAN/HCTZ



02371251



100/25 mg



NL1429



08/2019



APO-LOSARTAN/HCTZ



02371251



100/25 mg



NZ8846



05/2020



APO-LOSARTAN/HCTZ



02371251



100/25 mg



NZ8847



05/2020



APO-LOSARTAN/HCTZ



02371251



100/25 mg



NZ8845



05/2020



LOSARTAN (PRO DOC LIMITEE)



02394367



25 mg



498292



03/2019



LOSARTAN (PRO DOC LIMITEE)



02394367



25 mg



605344



02/2020



LOSARTAN (PRO DOC LIMITEE)



02394375



50 mg



498779



03/2019



LOSARTAN (PRO DOC LIMITEE)



02394375



50 mg



600046



06/2019



LOSARTAN (PRO DOC LIMITEE)



02394375



50 mg



603903



11/2019



LOSARTAN (PRO DOC LIMITEE)



02394375



50 mg



498284



03/2019



LOSARTAN (PRO DOC LIMITEE)



02394375



50 mg



603895



11/2019



LOSARTAN (PRO DOC LIMITEE)



02394383



100 mg



499008



03/2019



LOSARTAN (PRO DOC LIMITEE)



02394383



100 mg



605299



01/2020



LOSARTAN (PRO DOC LIMITEE)



02394383



100 mg



605297



01/2020



PMS-LOSARTAN



02309750



25 mg



498294



03/2019



PMS-LOSARTAN



02309750



25 mg



605342



02/2020



PMS-LOSARTAN



02309750



25 mg



611944



01/2021



PMS-LOSARTAN



02309769



50 mg



498285



03/2019



PMS-LOSARTAN



02309769



50 mg



600047



06/2019



PMS-LOSARTAN



02309769



50 mg



600091



06/2019



PMS-LOSARTAN



02309769



50 mg



603894



11/2019



PMS-LOSARTAN



02309769



50 mg



612025



01/2021



PMS-LOSARTAN



02309769



50 mg



612031



01/2021



PMS-LOSARTAN



02309769



50 mg



612679



01/2021



PMS-LOSARTAN



02309769



50 mg



616743



08/2021



PMS-LOSARTAN



02309777



100 mg



498864



03/2019



PMS-LOSARTAN



02309777



100 mg



602668



09/2019



PMS-LOSARTAN



02309777



100 mg



603816



09/2019



PMS-LOSARTAN



02309777



100 mg



605298



01/2020



PMS-LOSARTAN



02309777



100 mg



605300



01/2020



PMS-LOSARTAN



02309777



100 mg



613935



03/2021



PMS-LOSARTAN



02309777



100 mg



613936



03/2021



TEVA-LOSARTAN/HCTZ



02358263



50/12.5 mg



35349397A



09/2019



TEVA-LOSARTAN/HCTZ



02358263



50/12.5 mg



35344801A



09/2020

AAssessment is ongoing
Health Canada continues to work with companies and international regulatory partners, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, to assess the issue of nitrosamine impurities in certain sartan drugs, its root causes and mitigation measures. Health Canada's evaluation so far suggests that the nitrosamines may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug's API. They may also result from the reuse of materials, such as solvents or starting materials, that are contaminated with the impurities. An API is the active ingredient in a drug that produces an effect on the body. APIs are used in the manufacture of finished "dosage form" drugs (such as pills, capsules or tablets).A In December 2018, Health Canada requested all companies that market sartans in Canada to test products already on the market and those to be released in Canada for N-nitrosodimethylamineA(NDMA) and N-nitrosodiethylamineA(NDEA). Health Canada also recommended that companies consider using manufacturing practices that avoid the generation and presence of all nitrosamine impurities. Health Canada has tested more than 50 samples of sartan drugs and will continue to post results of any new samples it tests on its website.Health Canada continues to hold companies responsible for the safety and effectiveness of drugs sold in Canada and expects manufacturers to take any necessary actions to prevent the generation of nitrosamine impurities. The Department will take further steps as required to confirm that appropriate and timely action is taken to protect the health and safety of Canadians. Manufacturers of recalled sartan APIs Based on a review of information from a U.S. FDA inspection, Health Canada has found Hetero Labs Ltd. Unit 1 to be non-compliant with requirements for Good Manufacturing Practices (GMPs). AA non-compliant rating means that Canadian companies can no longer import drugs that contain APIs from this site unless they are medically necessary.A As previously communicated, Health Canada has also found the Chuannan site of Zhejiang Huahai Pharmaceuticals (ZHP) in China to be non-compliant with GMP requirements. This site manufactured valsartan that was found to contain nitrosamine impurities. All drugs containing valsartan manufactured by ZHP have beenArecalledAin Canada.AGMPs are internationally accepted standards that help ensure that drugs are consistently manufactured, tested, stored and distributed in a way that meets Canada's high safety and quality standards. A non-compliant rating does not necessarily indicate a product safety concern. It means that the Department has identified issues with how the company is following good manufacturing processes and procedures. Health Canada routinely inspects facilities or assesses inspection results from trusted international regulatory partners to make sure they meet these standards and maintains a database with inspection results. Health Canada does not generally proactively communicate on these ratings, but is updating Canadians at this time as part of its commitment to communicating its activities related to nitrosamine impurities in sartans.Health Canada continues to collaborate with international regulators on inspections of foreign manufacturers of sartans and will take action and update Canadians as needed. Related links

More information, including a complete list of recalled products related to this issue, and Health Canada's lab test results and test method.

Previous communications:

Health Canada information update (2018-12-20): Health Canada releases test results of certain sartan drugs



Health Canada information update (2018-11-29): Mylan-Valsartan voluntarily recalled as a precaution due to an impurity



Health Canada information update (2018-10-02): Health Canada finds Zhejiang Huahai Pharmaceuticals site non-compliant with requirements for the manufacture of drug ingredients



Health Canada information update (2018-09-13): Health Canada advises of a second impurity linked to recalled valsartan drugs



Health Canada information update (2018-09-10):AHealth Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA



Health Canada information update (2018-08-18):ATeva Canada expands recall of valsartan drugs to include additional lots, as a precaution



Health Canada advisory (2018-07-09):ASeveral drugs containing valsartan being recalled due to contamination with a potential carcinogen

A?galement disponible en franAaisASOURCE Health Canada
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