Novartis quickly pivoted from suspending distribution of its generic Zantac drugs to recalling them from the U.S. after determining they contain a suspected carcinogen. It is likely to be the first of a wave of recalls if the FDA and the industry follow last year’s pattern when it was determined many blood pressure drugs contained the same impurity.
Sandoz, the generics division of Novartis, today announced it is voluntarily recalling all lots of its 150 mg and 300 mg ranitidine hydrochloride capsules to the consumer level “because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.”
The Swiss drugmaker said it has not received any reports of adverse events related to use of the product as part of this recall but acknowledged NDMA is suspected of causing cancer.
There was no immediate announcement from the FDA, which had alerted the public Sept. 13 that it had been determined that NDMA could be produced during the manufacturing of ranitidine drugs. At the time, it said the amounts found in the drugs appeared to be less than would be found in common foods, and their risks seemed small.
That looks to all change now that Sandoz has confirmed its versions of the antacid Zantac contained NDMA levels above the FDA recommendation. The drugmaker had already halted distribution worldwide of its ranitidine drugs, a move that would have left unsold products on pharmacy shelves. It was an action that came as Canadian regulators asked drugmakers to stop distributing the drugs. India's Dr. Reddy's took the same step.
The industry was roiled last year when it learned that NDMA and two other suspected carcinogens could form during the manufacturing of the commonly used “sartan” blood pressure meds valsartan, losartan and irbesartan.
But the industry only just learned that the same kind of production phenomenon also applied to ranitidine-containing drugs. Regulators and the industry were tipped off to the problem by online pharmacy Valisure, which discovered it during its own testing. The company then filed a Citizen Petition calling on the FDA to seek a market recall of all of the drugs and establish standards for testing and manufacturing.
In an emailed statement today, Valisure said, it applauded Sandoz for initiating the voluntarily recall. "Valisure originally alerted the US FDA to the inherent instability and danger of all ranitidine products in June of 2019 and have been studying this issue in great detail...." it said. "Recall actions by companies such as Sandoz, and multiple governments around the world, send a strong message that consumer health and safety is of paramount concern. There is no acceptable cancer risk for a drug like this."