Dr Reddys recalls Ranitidine products in US over cancer-causing impurity
This recall follows the USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, Dr Reddys said in a filing.
New Delhi: Dr Reddy's Laboratories on Wednesday said it has initiated a voluntary nationwide recall of all its ranitidine medications sold in the US due to contamination with probable cancer-causing N-Nitrosodimethylamine (NDMA).
The recall started on October 1 after the United States Food and Drug Administration (USFDA) found the presence of NDMA in certain ranitidine products above the permissible levels.
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.
The recall has been initiated at the retail level for over-the-counter products and at the consumer level for prescription products of all of its ranitidine medications sold in the US due to confirmed contamination with NDMA above levels established by the USFDA, Dr Reddy's said in a filing to the BSE.
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.
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