Both Appco Pharma and Denton Pharma are voluntarily recalling all unexpired lots of their ranitidine products after finding they contained levels of a human carcinogen.
The recalls are the latest in a long series of recalls that began last September after the FDA issued a warning that ranitidine, commonly used to treat heartburn and other gastrointestinal issues, has the potential to produce N-nitrosodimethylamine, or NDMA, a cancer-causing chemical.
Appco Pharma, a New Jersey-based generic drugmaker, said consumers of their ranitidine hydrochloride capsules should discontinue use and talk to their physician or pharmacist about alternate treatments. FDA-validated tests conducted by Appco found NDMA above FDA-approved levels.
Denton Pharma, an affiliate of Indianapolis-based drug distributor Northwind Pharmaceuticals, said its recall is in response to a manufacturer's recall which also cited NDMA levels above what is FDA-approved.
Northwind is ceasing distribution of its ranitidine products in the U.S. while the manufacturer continues to test and investigate the products.
Denton advised consumers to immediately discontinue use, discard the remaining product and consult a physician or pharmacist about alternate treatments.
Neither company said it had received adverse event reports related to the recalls.