Amneal Pharma Recalls Certain Ranitidine Tablets

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Amneal Pharmaceuticals, LLC recalled certain lots of heartburn medication Ranitidine in the form of tablets and syrup for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels established by the U.S. Food and Drug Administration or FDA.

The generic and specialty pharma company is recalling 94 lots of Ranitidine tablets 150mg and 300mg of 30, 60, 100, 180, 250, 500, and 1000 count bottles as well as Ranitidine Syrup (Ranitidine Oral Solution) 15 mg/mL of 475 ml bottles.

The recall affects tablet lots with expiration dates between March 2020 and April 2021 as well as syrup lots between November 2019 and January 2021.

The recalled products, manufactured by Amneal, are prescription oral products and were distributed directly to wholesalers, distributors, retailers and repackagers across the U.S.

The company is yet to receive any confirmed reports of adverse events that can be directly related to this recall.

NDMA, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including meats, dairy products, and vegetables.

Ranitidine, a histamine-2 blocker, is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

The company said it is arranging for return of all recalled products, and urged anyone with an existing inventory of the product to quarantine them immediately. They have also warned consumers to stop using the product.

The recall follows a public statement issued by the FDA on September 13, alerting that some Ranitidine medicines, including Zantac over-the-counter or OTC, could contain NDMA at low levels.

After testing, several drug companies in the U.S. have started issuing recalls for Ranitidine, sold under the trade name Zantac among others, on confirmation of NDMA contamination above levels set by the FDA.

Those companies include Dr. Reddy's Laboratories Ltd., Perrigo Co. plc, Sanofi, Apotex Corp., Novitium Pharma, Lannett Co., Aurobindo Pharma USA, Inc. American Health Packaging and Sandoz Inc., the generics division of Swiss drug maker Novartis AG.

Walmart, Walgreens and CVS Pharmacy recently announced that they would stop sales of Ranitidine medications at their counters due to impurity concerns.

The FDA has also been investigating NDMA and other Nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers or ARBs from last year.

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