Teva has issued a voluntary recall of more than 500,000 bottles of the widely used blood pressure medication prazosin hydrochloride, citing unacceptable levels of potentially cancer-causing impurities.
The recall was issued Oct. 7 after deviation testing found that certain 1-, 2- and 5-mg prazosin capsules contained traces of the cancer-linked impurity N-nitroso prazosin impurity C that were “above acceptable intake limits."
Nitrosamines are a group of chemicals that can form in a variety of conditions, including during the manufacturing or storage of drugs. Many nitrosamines are carcinogenic.
The Teva recall is coded Class II, according to an FDA enforcement report issued late last week. Class II recalls cover products that may cause temporary or reversible adverse health consequences, or where the threat of serious negative health effects is remote.
Back in 2019, Teva and other manufacturers battled a wave of recalls of the hypertension drug losartan after certain lots were found to contain impurities believed to cause cancer. The cause of the impurities and recalls was ultimately traced back to tainted active pharmaceutical ingredients manufactured by India's Hetero Labs.
The API in those recalls contained N-Nitroso-N-methyl-4-aminobutyric acid above the FDA’s acceptable exposure limit.
Elsewhere, in 2022, Teva put out a recall for two lots of another of its hypertension drugs, Matzim LA (diltiazem hydrochloride), after testing found that the extended-release tablets failed to dissolve correctly.