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The United Kingdom: Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg／5ml Oral Solution (English only)

Medicines and Healthcare products Regulatory Agency (MHRA) announces that Rosemont Pharmaceuticals Limited is recalling all unexpired stock of Metformin Hydrochloride 500mg/5ml Oral Solution (lot number: 0LL0018) from pharmacies and wholesalers as a precautionary measure due to the identification level of an impurity above the acceptable limit. Following routine monitoring, the impurity, N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential, has been observed at a level above the acceptable limit.

Please refer to the following website in MHRA for details: http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-rosemont-pharmaceuticals-limited-metformin-hydrochloride-500mg-slash-5ml-oral-solution-pl-00427-slash-0139-el-21-a-slash-20

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

Currently in Hong Kong, there are 120 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 12 Jun 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/Thursday, Aug 26, 2021
Issued at HKT 16:00

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