Nostrum Laboratories is initiating the voluntary recall of two lots of its Metformin HCI extended-release tablets for people with diabetes.
According to an FDA news release, the Metformin HCI extended-release tablets (USP 750mg) were found to contain levels of nitrosamine impurities above the ADI limit of 96ng per day, as stipulated in the FDA Guidance Document issued in September 2020.
Affected products fall under the NDC 29033-056-01 and include two lot numbers — MET200101 and MET200301 — both of which expire in May 2022.
Kansas City, Mo.-based Nostrum Labs has not received any reports of adverse events related to the recall of its product that is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes mellitus.
The company is notifying its distributors by letter and is arranging for the return of all recalled products. Pharmacies carrying the tablets should return them to the place of purchase, while consumers should consult a healthcare professional to obtain a replacement or a different treatment option.
It could be dangerous for patients with Type 2 diabetes to stop taking the metformin without consulting a healthcare professional, the FDA said, and consumers should contact their physician or provider if they have experienced any problems related to the drug.