Amneal Pharma Recalls Certain Lots Of Nizatidine Oral Solution

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

The Bridgewater, New Jersey-based generic and specialty pharma company is recalling three lots of Nizatidine oral solution 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles, with expiration dates between April 2020 and December 2020.

These were distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal, directly to wholesalers who further distributed to retail pharmacies and consumers across the U.S.

The recalled product, manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

The company is yet to report any adverse events related to the recalled products.

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.

Nizatidine oral solution, a histamine-2 blocker, is approved for multiple indications, including treatment of heartburn and sour stomach, GI (gastrointestinal) ulcers and gastroesophageal reflux disease (GERD or acid reflux). It may be given for other indications too.

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

In November 2019, Amneal had recalled 94 lots of heartburn medication Ranitidine in the form of tablets and syrup for the potential presence of nitrosamine impurity NDMA, above levels established by the U.S. Food and Drug Administration or FDA.

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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