Appco Pharma LLC initiated a voluntary recall of all lots of its ranitidine hydrochloride capsules in the U.S. market due to high levels of a potentially cancer-causing substance called N-Nitrosodimethylamine, commonly known as NDMA.
The Piscataway, N.J.-based private generic pharmaceutical company did not receive any reports of adverse events directly related to the recalled products.
Consumers and distributors with an existing inventory of the recalled lots will be asked to stop distribution and return any stock to Appco's marketing partner ANI Pharmaceuticals Inc.
Ranitidine decreases the amount of acid created by the stomach. The drug is approved for multiple indications including treatment and prevention of stomach and intestinal ulcers and for the treatment of gastroesophageal reflux disease.
The company recalled a total of eight lots of 150-milligram and 300-milligram doses of the capsules with an expiration date ranging from April 2021 to May 2021.
Appco joins the list of companies that recalled several lots of their generic ranitidine drugs from the U.S. market due to high NDMA levels.
Earlier today, Mylan NV also issued a voluntary recall of its ulcer drug Nizatidine from the U.S. market due to elevated levels of NDMA as well.