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Why is Zantac Recalled?

Why is Zantac Recalled

Pharmacies across the nation are pulling Zantac and similar heartburn medications that contain ranitidine from store shelves after low levels of cancer-causing chemicals were found. The FDA is continuing to investigate ranitidine-containing drugs and they have not issued a formal recall yet. Pharmacy chains like CVS, Walgreens, and Rite Aid have suspended the sale of Zantac and their generic versions of the medication, however, to protect consumers from exposure to the probable carcinogen N-nitrosodimethylamine (NDMA).

FDA Issues Zantac Warning

On September 13, 2019, the Food and Drug Administration (FDA) issued a warning to patients and medical professionals that Zantac and various generic heartburn medications that contain ranitidine may have been contaminated with nitrosamine impurity NDMA. Results from laboratory tests indicate that NDMA is a probable human carcinogen. The environmental contaminant is sometimes found at very low levels in meats, dairy products, vegetables, and even water. When the chemical reactions used to manufacture ranitidine are not controlled, NDMA can form. Currently, the FDA is investigating the source of NDMA contamination in ranitidine products and the level of risk consumers may be facing. At this time, the FDA has not recommended that patients stop taking ranitidine-containing medications. 

What Is Ranitidine? 

Ranitidine is a common prescription and over-the-counter medication that is approved to treat conditions like heartburn and acid indigestion, ulcers, and gastroesophageal reflux disease. The histamine-2 blocker is known under its brand name Zantac, but a large number of generic versions exist as well. The name brand version is sold by the company Sanofi. So far, only Novartis/Sandoz and Apotex, which manufacture some of the generic versions of the drug, have recalled their products. 

What Should Consumers Do if They Take Ranitidine? 

Although the FDA has not currently recommended that people stop taking Zantac and other ranitidine products, the FDA states that consumers may wish to pursue other treatment options. Other over-the-counter and prescription medications are available to treat heartburn and similar conditions and people who wish to switch should speak with their doctors and pharmacists. Based on current information, there is no indication that other H-2 blockers have been affected by NDMA contamination. 

Patients who notice adverse effects after taking ranitidine should report these issues to the FDA’s MedWatch program and their injury lawyers right away. When medications like ranitidine cause injuries to consumers, victims can file personal injury claims against the drug manufacturers to recover damages. Additionally, doctors who prescribe dangerous medications, companies who distribute them, and pharmacies that sell them may be able to be held liable for injuries. 

Consumers who have already purchased over-the-counter Zantac and generic versions of ranitidine medications may be able to return them to their pharmacy for a refund. 

The FDA has issued a national recall of all Zantac drugs due to a carcinogenic ingredient known to cause cancer in humans.

FDA Recalls Zantac Drugs

Due to mounting consumer complaints and national lawsuits filed with Zantac cancer attorneys, the Federal Food and Drug Administration (FDA) has issued a national recall of Zantac, a popular drug used to treat heartburn and acid reflux problems in adults and some children with active intestinal ulcers. Alarming testing data shows a possible link to Zantac and certain cancers of the stomach, liver, bladder, pancreas, and colon.

The FDA is concerned about alarming test results that link ranitidine products (known by the brand name Zantac) to certain cancers in humans. Testing shows unacceptable levels of NDMA, a probable carcinogen (cancer-causing chemical), found in some ranitidine products. The levels of cancer-causing chemicals in Zantac have been found to be between 3,000 and 26,000 times higher than the levels determined to be safe by the FDA.

Ranitidine is a drug that’s available in a prescription version and an over-the-counter version. Prescription ranitidine comes as an oral tablet, oral capsule, oral syrup, and an injectable solution. Over-the-counter Zantac comes in an oral tablet and a liquid.

Zantac is usually prescribed for short periods of time, but some people with stomach ulcers and gastrointestinal disorders take it for longer periods. FDA testing shows that NDMA impurity levels increase significantly when ranitidine products are stored over time or at higher temperatures, including high temperatures products may be exposed to during distribution by retailers and handling by consumers. Testing also shows that ranitidine products with older manufactured dates show much higher levels of NDMA.

In 2020, the FDA requested all manufacturers of Zantac to recall both prescription and over-the-counter drugs from the market immediately. Major retailers and pharmacies including Kroger, Target, Walmart, CVS, Rite Aid, and Walgreens have pulled prescription and over-the-counter formulas of Zantac from their shelves. In addition, Sanofi, Zantac’s brand-name manufacturer, as well as 14 generic manufacturers have recalled the drug in the United States.

The FDA is advising consumers who take over-the-counter Zantac to stop taking any medications they currently have, and seek other drugs approved for the same or similar uses without possible cancer risks. Patients taking prescription Zantac or other ranitidine products are advised to consult with their doctor for a safe drug replacement without personal injury risks from NDMA impurities found in Zantac.

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