BRIDGEWATER, New Jersey — Amneal Pharmaceuticals, LLC, from Bridgewater, New Jersey announced that the company would recall several lots of its Ranitidine products because of N-Nitrosodimethylamine (NDMA) impurities found in its products. Scientists have identified NDMA as a potential carcinogen. NDMA exists in much of the food humans consume such as water, vegetables, meat, and dairy products. Introducing additional amounts of NDMA into the body could cause significant harm. Therefore, companies such as Amneal Pharmaceuticals recalled their Ranitidine-based products according to pharmacytimes.com and the U.S. Food and Drug Administration (FDA). The FDA asked pharmaceutical companies to continue testing their products for NDMA in amounts that could put people over the limit of NMDA daily consumption. The FDA said Amneal Pharmaceutical’s Ranitidine recall is voluntary and also acknowledged that Amneal Pharmaceuticals had not received any notifications that a patient fell ill after taking one of its Ranitidine products.
Amneal Pharmaceuticals recalled its Ranitidine, USP, in 150 mg and 300 mg doses as well as its Ranitidine Oral Syrup, also known as Ranitidine Oral Solution, USP. Amneal designed these products to treat stomach acidity. Ranitidine blocks histamine-2 which causes stomach acid. The FDA approved Ranitidine for uses such as treating and preventing stomach ulcers, treating and preventing intestinal ulcers, and treating symptoms associated with gastroesophageal reflux disease.
Amneal Pharmaceuticals sent the recalled products to their wholesalers, distributors, repacking companies, and retail outlets. Every company which received a recalled shipment of Ranitidine must return the product to Stericycle. Similarly, all consumers who purchased Amneal Pharmaceutical’s Ranitidine products must stop using the product immediately and contact Stericycle as well to arrange for a refund.
Consumers may contact Amneal Pharmaceuticals directly to report any adverse medical conditions associated with consuming Ranitidine. However, patients taking these recalled products who fall ill should contact their physicians or health care providers first. Additionally, consumers can report adverse conditions and illnesses to the FDA MedWatch program to report their issues.
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