Pfizer Hit With Class Action Suit Over OTC Zantac Labeling

A group of consumers filed a class action suit against Pfizer, alleging that the company knew or should have known that its over-the-counter heartburn drug Zantac (ranitidine) was contaminated with dangerous levels of NDMA and unsafe for consumption.

The complaint alleges that Pfizer marketed its OTC Zantac as safe and effective despite “evidence to the contrary,” noting that the drug’s original labeling did not list NDMA or disclose the contaminant’s properties as a probable carcinogen.

“NDMA would not be present if the medication were properly synthesized,” according to the complaint. The medications “expose users to NDMA well above the legal limit,” so they are “not fit for human consumption.”

Pfizer was the original NDA holder for OCT Zantac, manufacturing and controlling the drug from 2000 to 2006. The company and other prominent drugmakers, including the drug’s current brand name manufacturer, Sanofi, have recalled their ranitidine products. Pharmacy chains such as Walgreens, Rite Aid and CVS, have also followed suit.