WASHINGTON, D.C. — Amneal Pharmaceuticals, LLC, announced that it must recall from consumer stores, wholesalers, distributors, and customers, the heartburn medication known as Nizatidine. According to Nasdaq.com, Amneal Pharmaceuticals recall program is due to a potential nitrosamine impurity in its medication called N-Nitrosodimethylamine, or NDMA. The U.S. Food and Drug Administration (FDA) permits the consumption of small quantities of NDMA. However, the agency expressed concerns about the adverse health effects caused by ingesting amounts of NDMA higher than those tolerated by the FDA currently. Amneal Pharmaceuticals, based in Bridgewater, New Jersey, produces numerous drugs under generic names along with specialty pharmaceutical drugs. To this point, Amneal Pharmaceuticals is unaware of any adverse health events attributed to the consumption of Nizatidine.
Amneal Pharmaceuticals determined that recalling its Nizatidine oral solution in 15 mg/mL doses packaged in 480 mL bottles was the appropriate course of action to take in this circumstance. The recalled medication is available by prescription only. Amneal suggested that consumers check the expiration dates on the recalled oral solution to confirm the medication they have is part of the recall. The lots recalled expire in either April of 2020, or in December of 2020.
Amneal Pharmaceuticals’ recalled Nizatidine medication is prescribed by doctors to treat stomach distress such as treatment of ulcers, esophagitis, and heartburn typically associated with GERD, or gastroesophageal reflux disease.
The FDA had demanded a recall of Zantac and generic antacid medications containing ranitidine because of the possibility of excess NDMA consumption. The makers of Zantac, along with manufacturers of generic ranitidine products, withdrew their products from the marketplace out of an abundance of caution.
The FDA, in its safety announcement discussing the risks of NDMA consumption exceeding recommended limits, said that NDMA is identified as an environmental contaminant. The FDA also noted that NDMA is consumed by Americans daily in vegetables, meats, and dairy products as well.
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