Health Canada announces that Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA). The affected products are:
- MYLAN-Valsartan 40 mg (lot: 3048813-1)
- MYLAN-Valsartan 80 mg (lot: 3056368)
- MYLAN-Valsartan 160 mg (lot: 3056371)
- MYLAN-Valsartan 320 mg (lot: 3048815-1)
The products are being recalled as a precautionary measure. While the levels of NDEA found in the active pharmaceutical ingredient (valsartan), which is manufactured by Mylan Laboratories Limited in India, are low, they are above what is considered reasonably safe if the drug were taken over a lifetime. Given the length of time that the affected products have been on the Canadian market, this recall is being taken with an abundance of caution.
This latest recall is further to recent recalls and other actions taken in Canada and internationally as a result of NDEA and another impurity, N-nitrosodimethylamine (NDMA), being found in certain drugs. Both NDEA and NDMA are classified as probable human carcinogens, which means that long-term exposure could increase the risk of cancer.
Health Canada continues to work with companies and international regulatory partners to determine the scope and root cause of the issue, and to confirm that the necessary actions are taken to address it and prevent it from re-occurring. The Department will monitor these recalls. Should additional safety concerns be identified, Health Canada will take appropriate action and continue to inform Canadians.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../68448a-eng.php
In Hong Kong, there are 253 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (64 products), losartan (70 products) and olmesartan (17 products). All products are prescription-only medicines.
Regarding impurities in valsartan, a public announcement was issued on 6 Jul 2018, and letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Jul 2018, 9 Jul 2018, 25 Jul 2018 and 3 Aug 2018. Related news for the detection of impurities in sartan-containing products was also previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 6 Jul 2018, with the latest update posted on 28 Nov 2018.
In summary, there are four manufacturers, namely Zhejiang Huahai, Zhejiang Tianyu and Zhuhai Rundu in China and Hetero Labs Limited in India, reported to have detection of trace amounts of N-nitrosodimethylamine (NDMA) in the valsartan Active Pharmaceutical Ingredient (API) by various overseas drug regulatory authorities. The DH contacted the certificate holders of all registered valsartan products to follow up on the local impact regarding valsartan API produced by the above mentioned manufacturers.
For API produced by Zhejiang Huahai, there are 5 affected products (HK-61786, HK-61787, HK-61784, HK-61785 and HK-60794) marketed in Hong Kong. The DH instructed the certificate holders to recall all the products from the market as a precautionary measure on 6 Jul 2018, and the DH noted that all the recalls have been completed.
For API produced by Zhejiang Tianyu, amongst the registered pharmaceutical products containing valsartan, there is only one product namely Retoni Tablets 80mg (HK-65604) registered by Swiss Pharmaceutical Co Limited (Swiss Pharmaceutical) which has used API produced by Zhejiang Tianyu and is available in the local market. As confirmed with Swiss Pharmaceutical, the API was tested by the Taiwan Food and Drug Administration (TFDA) and the company has not received any notice from the TFDA for NDMA contamination. The DH collected samples of Retoni tablets for analysis and no NDMA was detected.
For API produced by Zhuhai Rundu and Hetero Labs Limited, the certificate holders confirmed that the valsartan products available in local market are not manufactured using API produced by Zhuhai Rundu or Hetero Labs Limited.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of the second impurity of N-nitrosodiethylamine (NDEA) in the valsartan API produced by Zhejiang Huahai, there should be no local impact as all valsartan products manufactured using API produced by Zhejiang Huahai have been recalled from the market.
In light of the European Medicines Agency’s (EMA), TFDA’s, the US Food and Drug Administration’s (FDA) and the above Health Canada’s announcement on the detection of NDEA in the valsartan API produced by Mylan Laboratories Limited in India, the certificate holders confirmed that the valsartan products available in local market are not manufactured using API produced by this company.
Regarding the EMA’s announcement on the detection of NDEA in the losartan API produced by Hetero Labs Limited, the FDA’s announcement on NDEA in the losartan API produced by Zhejiang Huahai, and the announcements issued by EMA, FDA and TFDA on NDEA in the irbesartan API produced by Aurobindo Pharma in India, the DH has contacted the certificate holders of all registered candesartan, irbesartan, losartan and olmesartan products and will continue to follow up on the impact of NDEA impurities on the products available in the local market.
So far, the DH has received 15 cases of adverse drug reaction related to valsartan, candesartan, irbesartan, losartan and olmesartan. None of them is concluded to be related to the presence of NDMA and/or NDEA. The DH will keep vigilant on any further updates on the matter issued by overseas regulatory authorities.
Patients who are taking the above products should not stop taking the medicines, but should seek advice from their healthcare professionals as soon as possible for proper arrangement.
Ends/Friday, Nov 30, 2018
Issued at HKT 15:00
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