More than half a million bottles of blood pressure medication have been recalled over high levels of a chemical compound that could cause cancer, the Food and Drug Administration said.
Parsippany, NJ-based Teva Pharmaceuticals USA recalled 580,844 bottles of Prazosin Hydrochloride earlier this month.
The medication is an alpha blocker taken to lower high blood pressure.
Testing revealed high levels of “N-nitroso Prazosin impurity C” in the drug, the FDA said last week.
The chemical’s concentration was so high that it surpassed the FDA’s safety limits for its potential to cause cancer.
Different versions of the drug – including 1 mg, 2 mg and 5 mg doses – were included in the recall affecting bottles with anywhere from 100 to 1,000 capsules.
The FDA recently classified the recall as Class II, which is the second-highest of three risk levels.
A Class II label indicates that use of the medication “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the agency.
As of Thursday morning, the drugmaker apparently had not provided instructions on whether consumers should toss or turn in bottles of the recalled product.
Teva Pharmaceuticals USA did not immediately respond to noti.group’s request for comment.
[Notigroup Newsroom in collaboration with other media outlets, with information from the following sources]
