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Generic ranitidine pulled from retailers’ shelves

Ranitidine is the generic name for the heartburn medication Zantac. Concerns over a potentially cancer-causing ingredient contained in the pills has prompted several manufacturers to recall generic ranitidine from the shelves of retailers like Walmart, Rite Aid and Walgreens across the country, including in Louisiana. 

At issue is a chemical called N-nitrosodimethylamine. NDMA, as it is more commonly known, gained notoriety last year as one of three carcinogenic chemicals found to have contaminated several cardiovascular medications. A flaw in the manufacturing process at pharmaceutical plants in India and China was the cause of the contamination of the cardiovascular medications. In the case of ranitidine, however, the problem may be an inherent instability in the chemical structure of the drug itself. 

A Connecticut-based laboratory found NDMA when testing ranitidine and compared their results with the recommended daily amounts from the Food and Drug Administration. Finding the levels to be higher than FDA recommendations, researchers reported their findings to the agency, which made an announcement regarding the elevated levels of NDMA found in ranitidine. The FDA also launched its own investigation into the drug, which is still ongoing. 

Although the FDA has not specifically asked drug-makers to recall ranitidine products, some have chosen to take this step. The manufacturer of brand-name Zantac is an exception. Despite the fact that FDA testing uncovered sufficiently elevated NDMA levels to warrant further investigation, a spokesperson for Zantac manufacturer Sanofi reported that NDMA levels in Zantac are comparable to those found in common foods. Therefore, although the spokesperson claims that the company is working with the FDA and conducting its own investigation, it has no plans to stop shipping Zantac to the United States. 

However, two manufacturers of generic ranitidine, Novartis and Apotek, are pulling their products from retailers’ shelves in the U.S. Meanwhile, another manufacturer, GlaxoSmithKline, which does not sell ranitidine in the United States, is pulling the products from retailers in Hong Kong and India. 

People who are taking the medication may wish to talk to their doctors about the recall. Meanwhile, those harmed by taking defective drugs may benefit from speaking with an attorney. 

 

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