Zantac Claims

In a new filing from attorneys representing over 70,000 former patients, Sanofi is accused of "widespread" destruction of employee emails tied to its 2019 recall of the drug, which preceded the FDA's ban in 2020. The pharmaceutical company and many others face lawsuits alleging they kept cancer risks from the drug hidden, and the new filing outlines alleged roadblocks the drug makers put up to delay the legal process, according to the plaintiffs' lawyers.

According to the company, Sanofi "did not intentionally destroy any emails related to the Zantac litigation," and "any suggestion to the contrary is false." Furthermore, "Sanofi has provided hundreds of thousands of pages of relevant discovery to the plaintiffs, including internal emails, test results, safety assessments, and correspondence with regulatory authorities."

April 1, 2020 – the FDA announced a market withdrawal request for all ranitidine drugs

On April 1, 2020, the FDA announced a market withdrawal request for all prescription and over-the-counter ranitidine drugs. This was the latest step in the ongoing investigation of the contaminant known as NDMA in ranitidine-containing medications, commonly known by the brand name Zantac. The agency determined that the impurity in some ranitidine drugs increases over time and, when stored at higher than room temperature, it may result in exposure to unacceptable concentrations of this impurity. As a consequence of this immediate market withdrawal request, ranitidine products would not be available for new or existing prescriptions or over-the-counter use in the country.

February 6, 2020 – Sanofi takes $186 million hit due to Zantac recall

Sanofi took a €169 million – or $186 million – write-down on Zantac in the fourth quarter following its October global recall of the drug. The recall torpedoed Sanofi's consumer health division, with sales decreasing 12.8% in the quarter to €246 million – $270.6 million. The drug manufacturer also targeted its own divestment efforts as a drag on the division overall.

January 6, 2020 – the 14th generic Zantac manufacturer recalls the drug

Denton Pharma Inc. dba Northwind Pharmaceuticals becomes the 14th generic Zantac manufacturer to issue a voluntary recall in the United States. The company took off the shelves all unexpired lots of its ranitidine and ceased distribution, too.

November 1, 2019 – the FDA states that the level of NDMA in Zantac is not dangerous

On November 1, 2019, the FDA released the results of its NDMA testing. The levels of NDMA ranged between 0.03 and 2.85 parts per million in 18 different products, and the agency said these concentrations are consistent with levels in common foods such as grilled or smoked meats.

October 18, 2019 – Sanofi, the brand name Zantac drug maker, also issues a recall

Sanofi issued a recall for over-the-counter brand-name Zantac 150, 150 Cool Mint, and Zantac 75. This was the first brand-name recall. The pharmaceutical company also recalled these drugs in Canada.

October 17, 2019 – the FDA releases a second method of detecting NDMA in ranitidine

The FDA developed another method of determining whether NDMA is present in ranitidine, known as Liquid Chromatography-Tandem Mass Spectrometry.

September 28 to October 2, 2019 – multiple retailers cease selling Zantac and its generics

During this period of time, multiple retailers across the country, including Walgreens, CVS Pharmacy, Rite-Aid, and Walmart, suspended all sales of brand-name Zantac and its generics.

September 24, 2019 – Sandoz, the first company to issue a voluntary Zantac recall

On September 24, 2019, the global leader in generic pharmaceuticals Sandoz issued a voluntary recall on Zantac. The specific drug the company took off the market is Ranitidine Hydrochloride Capsules 150mg and 300mg. Sandoz has not received any reports of negative health effects occurring due to the use of the product as part of this recall.

September 13, 2019 – the FDA issues a statement that some ranitidine drugs may contain NDMA

Dr. Janet Woodcock, the FDA's Director for Drug Evaluation and Research, issued a statement informing the public that some ranitidine medicines may contain NDMA. The agency released a method known as Liquid Chromatography-High Resolution Mass Spectrometry, which is used to determine the presence of the probable carcinogen in ranitidine. The FDA recommended manufacturers test their products and send samples to the agency for further testing.

September 9, 2019 – the laboratory Valisure discovers NDMA, a probable human carcinogen, in Zantac

In June 2019, the independent pharmacy and laboratory Valisure found N-nitrosodimethylamine – NDMA, for short – in multiple samples of Zantac. The Food and Drug Administration was promptly alerted and informed about the problem, and Valisure sent a Citizen's Petition urging the recall of all the affected drug lots. N-nitrosodimethylamine is a probable human carcinogen, meaning that it may lead to the development of malignant diseases such as liver cancer, stomach cancer, bladder cancer, pancreatic cancer, and esophageal cancer. It was found in Zantac by the Valisure researchers in excess of 3,000,000 ng per tablet, a concentration significantly higher than what health agencies determined to be safe for human ingestion based on lifetime exposure.

Developed by GlaxoSmithKline in 1983, Zantac is a medication containing ranitidine as the active ingredient and is used to treat heartburn. This is a condition entailing burning pain or discomfort in the upper chest and mid-chest, sometimes involving the neck and throat, that can worsen when lying down. The causes of heartburn include eating spicy food, drinking alcohol, overeating, or wearing tight clothing. Working as a histamine-2 blocker, Zantac decreases the amount of acid the stomach produces.