Aurobindo Pharma USA recalls stomach ulcer drug Ranitidine over impurities

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of Ranitidine tablets 150 mg Ranitidine capsules 150mg, 300 mg and syrup due to the detection of carcinogenic impurities, the company informed the USA Food and Drug Administration.

This is second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported carcinogenic impurity in the drug at low levels.

Earlier, Dr Reddys Laboratories had said it initiatedrecall of Ranitidine due to suspected impurities.

It said it suspended worldwide supplies of the drug owing to the FDA investigation.

"To date, Aurobindo Pharma USA, Inc. has not received any report of adverse events related to this recall," Aurobindo said in a letter to the US regulator.

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 (IARC) 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 FDA, in a statement issued on September 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.