Tests found some of the products were contaminated with Nitrosodimethylamine(NDMA).
Pharma major Dr. Reddy's Laboratories Ltd. and its subsidiaries issued a voluntary recall of all its ranitidine medicines, used to treat heartburn, from the US market.
"To date, Dr. Reddy's has not received any reports of adverse events related to the recall of Dr. Reddy's Ranitidine products. The recall includes all quantities in the US that are within expiry," the company said in a statement.
Ranitidine is available as an over-the-counter (OTC) and prescription drug. Ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach.
Tests found some of the products were contaminated with N-Nitrosodimethylamine(NDMA), the US Food and Drug Administration (USFDA) said on Wednesday in a statement.
This recall follows the USFDA's cautionary note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, it added.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Dr. Reddy's ranitidine products can be identified by NDC numbers on the product label. All Ranitidine products with expiration date September 2019 to June 2021 are being recalled, the company added.
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