The US Food and Drug Administration (FDA) announces that Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (lot number: MET200601) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued Sep 2020. This is an expansion of the recall initially announced on 2 Nov 2020.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0
In Hong Kong, the above product is not a registered pharmaceutical product.
Currently in Hong Kong, there are 124 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 5 Jan 2021. 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.
- On 22 Jul 2020, the DH endorsed licensed wholesaler dealers Suntol Medical Ltd and Hovid Limited to recall Glucofit Extended-Release Tablets 500mg (HK-64640) and Diabetmin XR Extended-Release Tablets 500mg (HK-63333) respectively.
- On 24 Aug 2020, the DH endorsed licensed wholesaler dealer Suntol Medical Ltd to recall Glucofit Film Coated Tablets 500mg (HK-64639).
- On 9 Oct 2020, the DH endorsed licensed wholesale dealer Star Medical Supplies Ltd to recall one batch of Metformin Denk 850 Tablets 850mg (HK-49776) (batch number: 21334).
So far, the DH has received 18 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/Tuesday, Jan 26, 2021
Issued at HKT 15:00
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