DUBLIN, Ireland – October 8, 2019 – Upon receiving communication from the U.S. Food and Drug Administration (FDA) regarding the potential for presence of N-nitrosodimethylamine (NDMA) in certain ranitidine-based products, Perrigo Company plc promptly initiated testing of its externally sourced ranitidine API and ranitidine-based products.
While the FDA is testing ranitidine products and is expected to provide guidance to manufacturers, at this time the FDA has not requested any market action, nor has it called for individuals to stop taking ranitidine. However, out of an abundance of caution, Perrigo has voluntarily halted the distribution of all ranitidine products while the FDA completes their analysis and provides guidance.
Perrigo has the highest commitment to consumer safety and will continue to cooperate with all applicable regulatory bodies around the world, some of which have taken various regulatory actions affecting products containing ranitidine. Consumers with concerns or questions about alternate therapies to treat their condition are encouraged to contact their health care provider.
NDMA is classified as a probable (at certain levels) human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
About Perrigo Company
Perrigo Company plc is dedicated to making lives better by bringing “Quality, Affordable Self-Care Products™” that consumers trust everywhere they are sold. The Company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at www.perrigo.com.
Brad Joseph, Vice President, Global Investor Relations & Corporate Communications, (269) 686-3373, E-mail: Bradley.Joseph@perrigo.com