Dr Reddy's decides to voluntarily recall all Ranitidine products in US

After Dr. Reddy's decided to temporarily suspend the supply of the drug ranitidine in September, they have now initiated a voluntary nationwide recall of all ranitidine medications sold in the US due to its contamination with probable cancer-causing compound, NDMA. This recall began 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. USFDA in a probe started 'checking for any adverse reactions of the drug' in September. Back then, the spokesperson of Dr. Reddy's quoted USFDA and stated, “...some ranitidine medicines, including the brand name Zantac, contained 'low levels' of NDMA.” 

NDMA – natural food contaminant 

N-Nitrosodimethylamine or NDMA, based on tests, has been classified for having a probable human carcinogenic element. Naturally, NDMA is an environmental contaminant that is usually found in foods like meat, dairy products, and some vegetables. After the suspension of supply, the drug is now being recalled at a retail level. The initiation of the recall is for the over-the-counter products and at the consumer level for prescription products sold in the US. Dr. Reddy's also informed BSE about the contamination of ranitidine with NDMA in a filing.  

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Dr. Reddy's recalls samples within expiry 

The USFDA, after September’s notice, has cautioned the patients and healthcare professionals again by saying that ranitidine has been checked positive for certain samples of NDMA. Dr. Reddy’s post the caution notice stated, "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." All ranitidine products with expiration dated September 2019 to June 2021 are being recalled, it added. In September, the drug firm Strides also recalled ranitidine tablets in the US due to contamination with NDMA. As per PTI reports, the shares of Dr. Reddy's Laboratories were trading at Rs. 2,827 per scrip on BSE, up 0.52% from the previous close. 

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USFDA's Older Statement  

The USFDA, in an earlier statement on September 13, had said that it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine. Being manufactured by several companies, Ranitidine needs examining in order to identify the levels of NDMA and evaluate any possible risk to patients. Though the USFDA did not call for individuals to stop taking Ranitidine in September, they asked patients, taking the prescription and wishing to discontinue its use, to talk to their health care professionals about other treatment options. 

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(With PTI Inputs)