WASHINGTON, D.C. — Stakeholders for the U.S. Food and Drug Administration (FDA) recalled the popular over-the-counter acid reflux medication Zantac recently because of the threat that the drug contains dangerously high levels of the suspected human carcinogen identified as N-nitrosodimethylamine (NDMA). The generic label for the active ingredient in Zantac is referred to as ranitidine. Now Amneal Pharmaceuticals, LLC recalled three lots of a related ulcer and heartburn medication containing ranitidine as well, because of the possibility that the drug also contains a dangerously high level of NDMA. The recalled lots are for the company’s Ranitidine Oral Solution and tablets. The FDA requested all ranitidine medications to be removed from shelves according to a news release published by the FDA.
Amneal notified its customers about its recall program. The company did not sell the products to the public directly. Instead, they conducted business with wholesalers, retailers, repackaging companies, and distributors. All of the companies in the supply chain are responsible for stopping shipment of the recalled goods and returning them to Amneal Pharmaceuticals, according to a statement released by the company.
The recalled lots are for Amneal’s 150 mg, 300mg, and Oral Solution in syrup form as well. Amneal also said that any customer who has their product should either return it to the point of purchase for a refund or discard it. The recalled drugs are available by prescription only. Patients with questions or concerns about the contaminated medication should consult their doctors.
Amneal Pharmaceuticals, LLC, said it has not aware of any reports of illnesses or injuries caused by its ranitidine products. The company described ranitidine is a histamine-2 blocker. According to Amneal Pharmaceuticals, LLC, a histamine-2 blocker is designed to block acid buildup in the stomach. FDA-approved use of ranitidine includes treatment of stomach ulcers, intestinal ulcers, as well as GERD, or gastroesophageal reflux disease. Although NDMA is consumed by Americans daily, the FDA expressed a concern that ingesting additional quantities of NDMA could increase a person’s cancer risk.
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