Dr Reddy’s Laboratories has recalled all its ranitidine medications sold in the US after certain samples of it were found contaminated with probable cancer causing constituent N-Nitrosodimethylamine (NDMA).
As per the statement from the company, process already started on October 1 when the United States Food and Drug Administration (USFDA) found traces of NDMA in certain ranitidine products above the permissable levels.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
This recall follows the USFDA’s caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, it added.
“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.
All ranitidine products with expiration dated September 2019 to June 2021 are being recalled, it added. Last month, drug firm Strides too recalled its ranitidine tablets in the US due to contamination with NDMA.