The US Food and Drug Administration (FDA) announces that Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on 5 Jun 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled. For details of the affected lot numbers, please refer to the website in FDA.
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 found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events that have been related to this recall.
Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750 mg were distributed by Time-Cap Labs, Inc. nationwide in the United States to wholesalers who further distributed to pharmacies.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride
In Hong Kong, the above products are not registered pharmaceutical products.
Currently in Hong Kong, there are 123 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 24 Sep 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.
- 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 dealers Suntol Medical Ltd to recall Glucofit Film Coated Tablets 500mg (HK-64639).
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/Tuesday, Oct 6, 2020
Issued at HKT 15:00
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