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[citation needed] Also by then, "a wave of recalls" had taken place. [21] Some of the lawsuits, which by October 2021 included over 100,000 plaintiffs, [5] were filed due to impending statute of limitations laws; estimates of how many people used Zantac have been given as high as 15 million. [citation needed] Facets of the legal rangling included:
In October 2019, Sanofi recalled all over-the-counter Zantac in the United States and Canada, [107] [108] [17] Perrigo issued a worldwide recall of ranitidine, [109] [17] Dr. Reddy's issued a recall of all ranitidine products in the United States, [110] [17] and Novitium Pharma recalled all ranitidine hydrochloride capsules in the US. [111] [17]
Ranitidine (Zantac) 2020 Worldwide Found to spontaneously break down into the carcinogen N-nitrosodimethylamine. Rapacuronium (Raplon) 2001 US, multiple markets Withdrawn in many countries because of risk of fatal bronchospasm. [2] Remoxipride: 1993 UK, others Aplastic anemia. [3] rhesus rotavirus vaccine-tetravalent (RotaShield) 1999 US
The FDA's advisory said people already taking Zantac, made by Sanofi, or generic forms of the antacid should stop and switch to other heartburn medications that do not contain ranitidine.
Sanofi acquired Zantac in 2017. Before that, other companies owned the drug. Peter Pitts, the former associate commissioner of the FDA, says these types of lawsuits are concerning for the industry.
In 2019, Dr. Reddy's recalled all ranitidine products in the US market due to contamination with the carcinogen N-nitrosodimethylamine (NDMA). [33] Months later, all brands of ranitidine were recalled and it was taken off the US market, as the carcinogen was an unavoidable byproduct. [34]
The U.S. Food and Drug Administration (FDA) in 2020 pulled Zantac and its generic versions off the market, triggering a wave of lawsuits. GSK settles another Zantac lawsuit in California Skip to ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]