A third blood pressure medication was recalled across the United States in the past several weeks, according to a notice updated on the U.S. Food and Drug Administration’s (FDA) website on Dec. 16.
The notice said that New Jersey-based Aurobindo Pharma USA Inc. is recalling Nebivolol tablets in 2.5 milligram doses in 30-count bottles, which are only available by prescription. Nebivolol, a type of beta blocker, is used to treat high blood pressure.
The reason for the recall is because of the “presence of nitrosamine drug substance related impurity,” adding that discovered N-nitroso nebivolol levels are above the “acceptable intake limit,” it said. N-nitroso nebivolol is a nitrosamine and is considered mutagenic.
It was first initiated by Aurobindo earlier this month. The FDA classified the recall as Class II on Dec. 16, which occurs when there is a low chance of injury or death, and a possibility of “adverse events” that may have irreversible effects. They are issued if the product can cause medically reversible or temporary health problems—or if there is a small chance of serious health consequences.
The lot numbers being recalled are: NB0224001A and NB0224001B. It has an expiration date of April 2027 and a National Drug Code, or NDC, of 59651-137-30, according to the FDA.
Nitrosamines are compounds that can increase the risk of cancer in individuals if exposed to them above levels established by the FDA, or for long periods of time, the agency says on its website.
“A person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA adds.
People who are taking medications with possible “nitrosamine impurities should not stop taking their medications” and should instead speak with a health care professional.
Nitrosamines can be found in small levels in the environment and foods, including “meat, vegetables, and dairy products,” the FDA says.
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