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.
Earlier, the FDA had stated that the levels of NDMA found in the drug ranitidine were mere trace amounts and that the risk of developing cancer was low. However, after further tests, the FDA announced its findings which contradicted its earlier statement.
Last year, a worldwide recall on medications called sartans was issued after there was evidence of NDMA contamination in these drugs. Sartans are a group of drugs given to individuals with hypertension. While the FDA has not stated that those requiring the medications must stop them at once. It has been recommended that individuals requiring ranitidine switch to a different class of medications to treat their acidity.