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3 heartburn drugs recalled amid cancer concerns

13 January 2020

The recall is due to the fact the medications may contain an impurity that causes cancer.

The FDA website said three lots of Nizatidine capsules are being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Ltd.

Regulators targeted Zantac and other ranitidine and nizatidine medicines past year, after receiving reports of batches being contaminated with nitrosamines, the carcinogenic impurity that previously triggered the recalls of sartan products.

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A known environmental contaminant found in water, and foods like meats, dairy products and vegetables, NDMA is classified as a probable human carcinogen, according to the International Agency for Research on Cancer (IARC).

Appco Pharma also recalled batches of ranitidine because of the potential presence of NDMA. The investigation has been going on since 2018.

The products Denton has recalled are unexpired and are between 150 mg and 300 mg. Ranitidine Capsules 150 mg and Ranitidine Capsules 300 mg were distributed nationwide.

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Mylan N.V. also announced a recall on Wednesday of three lots of Nizatidine, which is used to treat duodenal ulcers and acid reflux.

Two companies have announced they are recalling heartburn medications because they may include a carcinogen. NDMA can be unintentionally introduced into manufacturing through certain chemical reactions.

USFDA classifies a Class II recall as one in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

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3 heartburn drugs recalled amid cancer concerns