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The United States: Apotex Corp. issues voluntary nationwide recall of Metformin Hydrochloride Extended-Release Tablets 500mg due to the detection of N-nitrosodimethylamine (NDMA) (English only)

The US Food and Drug Administration (FDA) announces that Apotex Corp is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on 29 May 2020 to Consumer Level.

Apotex was notified by the FDA that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in Feb 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.

Please refer to the following website in FDA for details: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets

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 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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