(WAND) – It’s the third time in the past week that a recall has been issued for the generic version of a popular heartburn and ulcer drug, according to the FDA.
The drug is best known as Zantac.
Amneal Pharmaceuticals recalled dozens of lots of Ranitidine tablets, 150 mg and 300 mg, and Ranitidine Syrup, 15mL. The voluntary recall was issued on Tuesday.
The drugs may contain N-Nitrosodimethylamine (NDMA) at amounts above levels established by the Food and Drug Administration. NDMA is a nitrosamine. The FDA says nitrosamines can be found naturally in water, meats, dairy products and vegetables, but NDMA is also a probable human carcinogen.
According to Amneal there are no adverse effects being reported at this time.
This is the third call for the drug since last Wednesday.
Aurobindo Pharma USA issued a recall for capsules and syrup on Nov. 6. American Health Packaging issued a recall last Friday for Ranitidine Syrup which was distributed to wholesalers for use in hospital settings.
There have been nine recalls for Ranitidine since Sept. 23.
A statement released by the FDA states the levels found are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meat. But the FDA said they must test ranitidine in the body to fully understand if it forms NDMA.
