A manufacturer of ranitidine – the generic version of the heartburn drug Zantac – has issued a voluntary recall of the generic tablets in 75 and 150 milligram doses labeled by Walgreens, Walmart and Rite-Aid.
Walgreens is said to sell the product under the Wal-Zan brand name; the other two as ranitidine tablets.
The US Food and Drug Administration warned health professionals and patients to recall Friday by Apotex Corp. Over concerns ranitidine may contain low levels of nitrosamine impurity called N-nitrosodimethylamine (NDMA) which is considered a likely carcinogen.
The FDA had announced on September 1[ads1]3 that it had learned some ranitidine drugs, including some under the Zantac brand name, contained NDMA at low levels.
It is now testing multiple manufacturers ranitidine products for presence of NDMA above permitted levels and assessing possible effects on patients at levels found, as well as what manufacturers can do to reduce or eliminate nitrosamine in medications.
Canada has requested that companies stop distributing ranitidine drugs there until it considers NDMA.
Pharmaceutical manufacturer Sanofi, which markets Zantac in the United States, has not provided any recalls.
The FDA noted in its notice Friday that not all ranitidine drugs marketed in the United States are recalled, and that it is not recommended for individuals to stop taking all ranitidine drugs at this time.
It said that several medications are approved for the same or similar use as ranitidine.
FDA September 24, on a voluntary recall by Sandoz Inc. of 14 mass prescription ranitidine capsules for the detection of NDMA above FDA acceptable levels.
Sandoz said it has not received any reports of adverse effects related to the use of the products during recall.
Prescription ranitidine is approved for several indications, including the treatment and prevention of ulcers and intestines and the treatment of gastroesophageal reflux disease.
The FDA said that patients taking prescription ranitidine who wish to discontinue use should talk to health care professionals about other treatment options.
Apotex said it had learned from FDA and other world bale regulators that regardless of manufacturer, some ranitidine drugs contain low levels of NDMA.
It said it had not received any reports of adverse events related to the use of the product.
identified by the multi-digit national drug code number on the product label and listed on the FDA site.
NDMA is among nitrosamine impurities whose detection of the active pharmaceutical ingredient valsartan has led to recalls of some versions of angiotensin II receptor blocking drugs prescribed for high blood pressure over the past year.
NDMA is considered carcinogenic by prolonged exposure at certain levels.