The recalls of generic Zantac tainted by a suspected carcinogen continue to roll in. Two more companies have announced recalls of 18 lots of ranitidine heartburn meds in 150 mg and 300 mg doses.
Indianapolis-based Denton Pharma, which does business as Northwind Pharmaceuticals, voluntarily recalled 10 lots of ranitidine manufactured by Glenmark because they were found to contain unacceptable levels of the impurity N-nitrosodimethylamine (NDMA). Piscataway, New Jersey-based Apco Pharma recalled eight lots that it had manufactured.
This came even as the breadth of the drug retrievals widened with Mylan’s voluntary recall last week of three lots of nizatidine capsules because the API in them also contained unacceptable levels of NDMA. It was the first time nizatidine, a drug used for short-term treatment for duodenal ulcers, had been identified as an NDMA-carrying culprit.
The nizatidine recall follows months of others along with pharmacy actions to remove popular heartburn medicine Zantac and its generics from the reach of consumers after positive NDMA testing triggered concerns.
The FDA last fall reported trace amounts of the contaminant had been found in both branded and generic versions of the drug, triggering a series of recalls that lasted weeks. That was all preceded by the initial discovery in 2018 of NDMA and other potential carcinogens in certain “sartan”-based blood pressure meds.
It was determined that NDMA can be created during manufacturing and also is found in solvents often used in the process. But a third-party lab also reported it determined NDMA can materialize during storage or shipment in drugs that initially did not test for unacceptable levels.
The agency has assured consumers that the risk is small, saying the levels of NDMA found in these drugs is equivalent to that often found in “grilled or smoked meats.” The agency has also warned it’s much riskier for consumers to quit taking these drugs than the possibility of getting cancer from them.