FDA Issues To Recall Another Heartburn Drug

FDA Issues To Recall Another Heartburn Drug

Introduction

On April 15, the FDA announced to recall Nizatidine Oral Solution, after finding the presence of the cancer-causing chemical N-Nitrosodimethylamine (NDMA).

Amneal Pharmaceuticals, following the announcement, declared for a nationwide recall of the generic oral heartburn medication nizatidine.

A similar nationwide recall was made on Zantac after the active pharmaceutical ingredient, ranitidine was found to produce high levels of NDMA when in storage. The presence of NDMA in Zantac surfaced in September 2019, when an independent pharmacy found high levels of the carcinogenic chemical in all doses and lots of the widely used heartburn drug.

More than 140 product liability lawsuits and class action cases have been filed throughout the federal court system, each raising similar allegations that the exposure to the active ingredient in Zantac, causes bladder cancer, kidney cancer, colorectal cancer, stomach cancer, and other forms of cancer.

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.