Aurobindo Pharma USA is recalling tablets due to levels of nitrosamine.
A pharmaceutical company is voluntarily recalling a blood pressure medication due to a potential cancer risk, federal regulators said.
The U.S. Food and Drug Administration said that Aurobindo Pharma USA is recalling recalling two lots of quinapril and hydrochlorothiazide tablets due to levels of nitrosamine.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables, the FDA said.
“Everyone is exposed to some level of nitrosamines,” the agency said in a statement. “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
To date, Aurobindo Pharma USA has not received any reports of adverse events related to this recall, the FDA said.
Quinapril and Hydrochlorothiazide are fixed-combination tablet for the treatment for hypertension to lower blood pressure.
The company began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.
Several Product Recalls
Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication, the FDA said.
Qualanex, which handles recall-product withdrawal management services, will notify distributors and customers on behalf of Aurobindo Pharma USA by phone to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.
Aurobindo Pharma USA is arranging for return of all recalled products to Qualanex.
Based in East Windsor, N.J., Aurobindo Pharma USA is a subsidiary of the Indian pharmaceutical company Aurobindo Pharma Ltd.
Aurobindo Pharma Ltd. has recalled several products this year including moxifloxacin ophthalmic solution — an antibiotic used to treat eye infections like bacterial conjunctivitis, according to Endpoints News.
In January, Aurobindo voluntarily recalled a lot of polymyxin B for injection after a hair was found in a vial within the lot.
The company, which has been subject to several FDA inspections, also shut down its site in Dayton, NJ earlier this year, eliminating 99 jobs in the process.