Health Canada announces that Apotex Inc. is recalling 9 lots of APO-Metformin 500 mg Extended Release Tablet (lot number: PK3968, PK3969, PX5336, PY7174, PY7175, RF6463, RF6464, RF6465 and RF6466) from wholesalers and retailers because the affected lots contain or may contain the presence of N-nitrosodimethylamine (NDMA) above the interim acceptable concentration limit.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../73339r-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 product has not been imported into Hong Kong.
Currently in Hong Kong, there are 122 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 various overseas drug regulatory authorities, and was posted on the Drug Office website since 5 Dec 2019, with the latest update posted on 12 Jun 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. The following is the main content of the press statement issued previously:
- On 11 Mar 2020, the DH endorsed a licensed wholesale dealer, the International Medical Company Ltd, to recall 3 batches of Metformin-Teva 500mg Tablets (HK-60334) (batch number: 16532717, 16532817 and 16532917) from the market due to the potential presence of NDMA in the product.
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/Monday, Jun 15, 2020
Issued at HKT 15:00
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