Aurobindo Pharma USA Inc. is conducting a voluntary recall of Ranitidine tablets 150 mg, Ranitidine capsules 150mg, 300 mg and syrup due to detection of carcinogenic impurities, the company informed the U.S. Food and Drug Administration on Friday.
Aurobindo Pharma is the second Hyderabad-based drugmaker, after Dr Reddy's Laboratories Ltd., to initiate a voluntary recall after the U.S. FDA announced an investigation into the reported carcinogenic impurity in the drug.
"To date, Aurobindo Pharma USA Inc. has not received any report of adverse events related to this recall," it said in a letter to the U.S. FDA.
NDMA (nitrosodimethylamine) is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on cancer classification.
Ranitidine is used to decrease the amount of acid created by the stomach and relieves heartburn associated with acid indigestion and sore stomach.
The U.S. FDA, in a statement issued Sept. 13, had 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.
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