Class Action Filed Regarding Ascend Laboratories’ Alleged Manufacturing, Distribution, and Sale of Generic Metformin That Contains Dangerously High Levels of N-nitrosodimethylamine
Kehoe Law Firm, P.C. is making consumers aware that on April 15, 2020, a class action lawsuit was filed against Ascend Laboratories, LLC (“Ascend”) in United States District Court, District of New Jersey, “regarding Defendant’s [alleged] manufacturing, distribution, and sale of the generic medication metformin that contains dangerously high levels of N-nitrosodimethylamine (‘NDMA’), a carcinogenic and liver-damaging impurity.” [Emphasis added.]
According to the complaint:
Metformin is a prescription medication that has been sold under brand names such as Glucophage. Metformin is used to control high blood sugar in patients with type 2 diabetes. However, Ascend’s manufacturing process has caused metformin to contain dangerously high levels of NDMA.
NDMA is a semivolatile organic chemical. According to the U.S. Environmental Protection Agency, NDMA ‘is a member of N-ni-trosamines, a family of potent carcinogens.’ While NDMA is not currently produced in the United States other than for research purposes, it was formerly used ‘in production of liquid rocket fuel,’ among other uses. NDMA is listed as a ‘priority toxic pollutant’ in federal regulations. See 40 CFR § 131.36. Exposure to NDMA can cause liver damage and cancer in humans. NDMA is classified as a probable human carcinogen, and animal studies have shown that ‘exposure to NDMA has caused tumors primarily of the liver, respiratory tract, kidney and blood vessels.’
On March 2, 2020, Valisure, an online pharmacy registered with the U.S. Drug Enforcement Agency and Food & Drug Administration, ‘detected high levels of NNitrodimethylamine (‘NDMA’) in specific batches of prescription drug products containing metformin.' This included metformin manufactured by Ascend.
Ascend had not yet issued a recall of metformin and continues to tout on its website that it is ‘committed to quality and safety.’ However, these representations are false, as Defendant’s metformin medication contains the carcinogenic impurity NDMA. [Emphasis added.]
Purchasers of Metformin Manufactured by Ascend Laboratories