Novartis: Sandoz recalls stomach drug in the US
(CercleFinance.com) - Sandoz, the generics unit of Swiss drugmaker Novartis, said that it has issued a voluntary recall of its Ranitidine stomach drug in the US, because of contamination with a substance that could cause cancer.
Sandoz is voluntarily recalling all quantities and batches, due to NDMA exceeding levels established by the FDA, it said.
NDMA is a known environmental contaminant found in water and foods, including meat, dairy products, and vegetables. It is classified as a probable human carcinogen.
Ranitidine is indicated for the treatment of benign gastric ulcer, reflux esophagitis and post-operative peptic ulcer.
To date, Sandoz has not received any reports of adverse events relating to use of the product, it said.
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