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Dr Reddy's Laboratories recalls anti-ulcer drug ranitidine from US market

The recall comes after USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine

BS Reporter  |  Hyderabad 

Dr Reddy's
Dr Reddy's

Dr Reddy's Laboratories Limited on Wednesday confirmed that it had initiated a voluntary nationwide recall of several lots of its ranitidine from the US market over confirmed contamination with N-Nitrosodimethylamine (MDMA) beyoond levels established by the US Food and Drug Administration (US FDA).

The recall comes after USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, a medication used to relieve heartburn associated with indigestion and sour stomach, and also treat gastric ulcers. To date, Dr Reddy's has not received any reports of adverse events related to the recall of the company's ranitidine products, it said.

NDMA is classified as a probable human carcinogen based on results from laboratory tests.

First Published: Wed, October 23 2019. 15:00 IST
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