HYDERABAD: After suspending worldwide shipments of its drug Ranitidine following the ongoing probe by the US FDA into the reported carcinogenic impurity in it at low levels, Dr Reddys on Wednesday said it had initiated a voluntary recall of several lots from the US market.
The city-based drugmaker said in a filing with bourses that the recall, which began on October 1, is 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 US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by FDA.
"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. The recall includes all quantities in the US that are within expiry," Dr Reddys said. Ranitidine is used to decrease the amount of acid created by the stomach.
Dr. Reddy's had earlier told PTI that it was still evaluating the potential impact of the issue and as a precautionary measure, was suspending all worldwide shipments of Ranitidine products until the outcome of the investigation by the FDA was available.
The FDA in a statement on September 13 said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine and examining levels of NDMA in Ranitidine and evaluating any possible risk to patients.
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.