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Canada: Certain Metformin diabetes drugs recalled due to the presence of NDMA: Update: RAN-Metformin 500 mg and 850 mg (English only)

Health Canada announces that Ranbaxy Pharmaceuticals Canada Inc. is recalling six lots of its prescription RAN-Metformin 500 mg and 850 mg drug from the Canadian market.

Company testing identified two lots (AJY8006A and AJY8007A) with levels of N-nitrosodimethylamine (NDMA) above what is considered acceptable if the drug were to be taken over a lifetime. The company is recalling an additional four lots (AJY8005A, AJY8005B, AJY8008A and AJZ8005A) as a precautionary measure because they contain NDMA close to the acceptable limit.

Please refer to the following website in Health Canada for details: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../72287a-eng.php

In Hong Kong, the above product is not a registered pharmaceutical product.

Currently in Hong Kong, there are 125 registered pharmaceutical products containing metformin. All products are prescription-only medicines.

Related news on the detection of N-nitrosodimethylamine (NDMA) in metformin products was previously issued by Singapore Health Sciences Authority and other overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Dec 2019, with the latest update posted on 5 Feb 2020. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Dec 2019. The DH has contacted the certificate holders of all registered metformin products for follow up on the local impact of the issue, and collected samples of metformin-containing products in the local market for analysis. When there are any health risks identified and posed to the public, a press statement will be issued as soon as possible.

So far, the DH has received 17 cases of adverse drug reaction related to metformin. None of them is concluded to be related to the presence of NDMA. The DH will remain vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary.

Patients who are taking metformin-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement.

Ends/Thursday, Feb 27, 2020
Issued at HKT 17:00

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