April 3, 2020
FDA takes action, issues immediate removal request of generic Zantac (ranitidine) medications
A series of recalls involving the name-brand heartburn drug Zantac (ranitidine) and similar generic versions culminated April 1 in the FDA asking drug manufacturers to immediately withdraw all prescription and over-the-counter ranitidine products, including generic ones, from the U.S. market due to concerns that they may contain toxic N-Nitrosodimethylamine (NDMA).
NDMA may cause stomach, bladder, kidney, pancreatic, colon and other cancers in humans, the World Health Organization has found. The FDA began investigating the toxin in blood pressure and heart failure medications in 2018. The agency said it also found “unacceptable levels” of NDMA in some ranitidine products, H2 (histamine-2) blockers used to decrease the amount of acid in the stomach and treat conditions such as heartburn and indigestion.
The FDA described its request to withdraw all ranitidine products as the latest step in its ongoing investigation. Ranitidine will no longer be sold over the counter and will not be available for new or existing prescriptions.
The FDA’s request came roughly six months after Zantac manufacturer Sanofi recalled the named-brand drug in October 2019. Several generic manufacturers followed with a series of recalls affecting certain batches of the drug, including Appco Pharma’s recall of prescription-only 150mg and 300mg capsules that were set to expire in April or May of 2021. Northwind Pharmaceuticals’ recall affected all unexpired lots of 150mg and 300mg ranitidine tablets that were packaged by Denton Pharma, in addition to similar recalls by Glenmark Pharmaceutical Inc., Sandoz Inc., and Apotex Corp.
Motley Rice medical attorneys have extensive experience litigating for patients who have suffered severe adverse effects and complications caused by prescription and over-the-counter drugs, including heartburn medications. In addition to handling Zantac claims, our attorneys represent clients with chronic kidney disease and failure related to proton pump inhibitors (PPI), used to treat GERD, frequent heartburn, ulcers, esophagitis and other conditions related to the over-production of stomach acid.