Zantac OTC Recalled By Sanofi Due To Possible Contamination Concerns

Ranitidine is the active ingredient in Zantac®, which prevents or relieves heartburn by reducing the production of stomach acid.

On October 18, 2019, Sanofi, which manufactures Zantac OTC, announced: “As a precautionary measure, Sanofi will conduct a voluntary recall of Zantac OTC (over-the-counter) in the U.S. and Canada. This recall is being taken due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA). The company is working with health authorities to determine the level and extent of the recall. On September 13, 2019, the U.S Food and Drug Administration and Health Canada issued public statements alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. Evaluations are ongoing on both drug substance (active ingredient) and finished drug product. Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues. Active ingredients used in Sanofi’s ranitidine products outside of the U.S. and Canada are sourced from different suppliers. Sanofi is committed to transparency and will continue to communicate results with health authorities from the ongoing testing, and work with them to make informed decisions based on available data and evidence. Sanofi encourages anyone using Zantac OTC to speak with their health care providers or pharmacists if they have any additional questions.”

Source

On September 13, 2019, the FDA issued a safety information announcement stating: “FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

“Ranitidine is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach. Over-the-counter Ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription Ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.”

Source

If you or a loved one suffered injuries (or worse) as a result of Zantac or another drug in the United States, you should promptly seek the legal advice of a drug claim lawyer in your state who may investigate your drug claim for you and represent you in a claim against a pharmaceutical company, if appropriate.

Visit our website or call us toll-free in the United States at 800-295-3959 to find drug claim lawyers in your state who may assist you.

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This entry was posted on Tuesday, October 22nd, 2019 at 5:25 am. Both comments and pings are currently closed.

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