The US Food and Drug Administration (FDA) announces that Viona Pharmaceuticals Inc., is voluntarily recalling 23 lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg at the consumer level. The reason for the recall is an out of specification result observed for one lot of the product (Lot number: M008132), “N-nitrosodimethylamine (NDMA) (By GC- MS/MS)” test at 17 Month(s), 25°C/60%RH long-term stability samples. In an abundance of caution, the firm has decided to voluntarily recall 23 batches which have determined having a valid shelf life within the US market. For details of the affected lot numbers, please refer to the website in FDA.
This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.
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. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have 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/viona-pharmaceuticals-inc-issues-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 118 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 29 Dec 2021. Letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Dec 2019.
The following metformin products were affected and recalled from the Hong Kong market: HK-60334 (lot: 16532717, 16532817 and 16532917), HK-64640, HK-63333, HK-64639 and HK-49776 (lot: 21334) on 11 Mar 2020, 22 Jul 2020, 24 Aug 2020 and 9 Oct 2020.
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 keep vigilant on any safety update on detection of impurities in metformin products issued by overseas regulatory authorities.
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/Friday, Jan 14, 2022
Issued at HKT 15:00
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