Dr Reddy’s Laboratories voluntarily recalls all Ranitidine products in US

G Naga Sridhar Hyderabad | Updated on October 23, 2019 Published on October 23, 2019

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The recall includes all quantities in the US that are within expiry

Pharma major Dr Reddy’s Laboratories Ltd has initiated a voluntary nationwide recall of all its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the US Food and Drug Administration (USFDA).

The recall, at the retail level for over-the-counter (OTC) products and at the consumer level for prescription products, had commenced on October 1, 2019, the Hyderabad-based company announced on Wednesday.

All ranitidine products with expiration dated September 2019 to June 2021 are being recalled.

“This recall follows the USFDA’s caution note alerting patients and health care professionals that NDMA was found in certain samples of ranitidine. To date, Dr Reddy’s has not received any reports of adverse events related to the recall of Dr Reddy’s Ranitidine products,’’ it said in a statement.

The recall includes all quantities in the US that are within expiry.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine is available as OTC and prescription drug. The OTC ranitidine tablets are used to relieve heartburn associated with acid indigestion and sour stomach. OTC Ranitidine Tablets are also used to prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages.

On September 13, the US drug regulator said it was evaluating the presence of this impurity and the impact (if any) of this impurity on patients.

Dr Reddy’s scrip is trading at Rs 2828.90 on the Bombay Stock Exchange (BSE) on Wednesday by the noon with a gain of 0.59 pc over previous close.

Published on October 23, 2019
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