The US Food and Drug Administration (FDA) announces that Bayshore Pharmaceuticals, LLC is voluntarily recalling one lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles (lot number: 18641) and one lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles (lot number: 18657) within expiry to the consumer level due to the detection of N-nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit (ADI). This product was manufactured by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in Jun 2019, for distribution in the United States by Bayshore.
Bayshore was notified by the FDA that one lot (lot number: 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was tested and showed results for NDMA levels in excess of the ADI and recommended recall of the one tested lot.
Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from 8 lots of Metformin Hydrochloride Extended-Release Tablets manufactured using same Active Pharmaceutical Ingredient (API) lot of the failed lot. Out of 8 lots, one lot (lot number: 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg and one lot (lot number: 18641) of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg have showed NDMA levels in excess of the ADI. Hence, Bayshore has decided to recall the two lots (lot number: 18641 and 18657). To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.
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/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended
In Hong Kong, the above products are not registered pharmaceutical products.
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 14 Jul 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.
- On 22 Jul 2020, the DH endorsed licensed wholesaler dealers Suntol Medical Ltd and Hovid Limited to recall Glucofit Extended-Release Tablets 500mg (HK-64640) and Diabetmin XR Extended-Release Tablets 500mg (HK-63333) respectively.
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/Friday, Aug 21, 2020
Issued at HKT 15:00
|
