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The United States: Marksans Pharma Limited issues voluntary nationwide recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, due to the detection of N-Nitrosodimethylamine (NDMA) (English only)

The US Food and Drug Administration (FDA) announces that Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 (expiry date: 12/2020), to the consumer level. FDA analysis has found the product to contain N- Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA 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-voluntary-nationwide-recall-metformin-hydrochloride-extended-release

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

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 2 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/Saturday, June 6, 2020
Issued at HKT 13:30

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