NDMA Contamination Leads To Another Recall

NDMA Contamination Leads To Another Recall

Introduction

The latest drug to undergo recall due to high levels of the cancer-causing chemical N-Nitrosodimethylamine (NDMA) is metformin, a medication used to control high blood sugar in type-2 diabetes patients.

The Food and Drug Administration (FDA) asked five unidentified drug manufacturers to voluntarily recall the widely used diabetes drug. The federal regulators also issued a metformin NDMA alert to the patients and healthcare professionals, warning about the presence of the toxic chemical in a higher-than-acceptable level that could potentially cause cancer.

The recall was the result of a citizen’s petition filed by the independent online pharmacy Valisure, who urged the FDA to issue metformin recalls in March 2020, after finding high levels of NDMA during independent testing. The FDA confirmed findings on some lots that Valisure had raised concerns about, and not all of them were agreed.

Lately, popular heartburn drug Zantac and blood pressure medication Valsartan also faced a widespread recall post the detection of the toxic chemical. The users of both drugs have reported developing various types of cancers following long-term use, including breast cancer, bladder cancer, stomach cancer, testicular cancer, and other injuries.

More than 230 Zantac lawsuits are pending in the Southern District of Florida. The lawsuits are consolidated and centralized before U.S. District Judge Robin L in Florida under MDL No: 2924, for coordinated discovery and pretrial proceedings.

Nearly 130 product liability lawsuits and class action claims involving Valsartan are currently pending in the federal court system. Valsartan claims are consolidated under MDL No. 2875 in the United States District Court, District of New Jersey, presided by Judge Robert B. Kugler, U.S.D.J, and Hon. Joel Schneider, U.S.M.J.