The US Food and Drug Administration (FDA) announces that Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake limit.
Granules’ test results showed NDMA levels above the FDA acceptable limit in one out of the twelve batches distributed to the United States market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market. For details of the affected lots, please refer to the website in FDA.
Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.
Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are not affected by this recall.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
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 15 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/Tuesday, Jul 7, 2020
Issued at HKT 16:00
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