Medicine recalls

Canada: Recall: APO-Metformin 500mg Tablet (Extended-Release)

Health Canada announces that Apotex Inc. is recalling 8 lots of APO-Metformin 500mg Tablet (Extended-Release) (lot number: NV3242, NV3244, NV3245, NV3243, NV3247, NV3248, PX5334, PX5335) from wholesalers, healthcare establishments and retailers due to presence of N-nitrosodimethylamine (NDMA) above the interim acceptable concentration limit in affected lots.

Please refer to the following website in Health Canada for details: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../72281r-eng.php

In Hong Kong, Apo-Metformin XR 500 Modified-Release Tablets 500mg (HK-65083) is a pharmaceutical product registered by Hind Wing Co Ltd (Hind Wing), and is a prescription-only medicine. As confirmed with Hind Wing, the affected lots have not been imported into Hong Kong.

Currently in Hong Kong, there are 124 registered pharmaceutical products containing metformin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 17 cases of adverse drug reaction related to metformin. None of them is concluded to be related to the presence of N-nitrosodimethylamine (NDMA).

Related news on the detection of NDMA in metformin products was previously issued by Singapore Health Sciences Authority (HSA) and other overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Dec 2019, with the latest update posted on 4 Feb 2020. Letters to inform local healthcare professionals were issued by the DH on 6 Dec 2019. The DH has contacted HSA for further information regarding the detection of NDMA in metformin products and reply is pending. The DH has contacted the certificate holders of all registered metformin products for follow up on the local impact of the issue. The DH has collected samples of metformin-containing products in the local market for analysis. When any health risks are posed to the public, a press statement will be issued as soon as possible. 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/Wednesday, Feb 5, 2020
Issued at HKT 15:00

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