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Teva Pharmaceuticals has voluntarily recalled over 580,000 bottles of its Prazosin Hydrochloride blood pressure capsules after FDA tests found elevated levels of potentially cancer-causing chemicals.
The recall was issued on October 7 after tests found that 1, 2, and 5 mg Prazosin capsules distributed nationwide contained “above acceptable intake limits” of the cancer-linked impurity N-nitroso Prazosin impurity C.
Prazosin, also known as Minipress, is an alpha-blocker used to treat high blood pressure, according to the Cleveland Clinic.
Last week, the FDA classified the recall as Class II, indicating that the drug may cause temporary or reversible health effects, but serious harm is unlikely.
Teva USA’s Health Hazard Assessment rated the overall patient risk as medium, according to a memo from the California Board of Pharmacy. As of Thursday, the company said it has not received any “relevant complaints” related to the product.
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The recall is classified as Class II by the FDA, meaning there is a risk of temporary or reversible health effects (Getty Images)
“Prazosin is indicated for the treatment of hypertension, to lower blood pressure, and there are many alternative treatments available to patients,” a company spokesperson told NBC Chicago in a statement. “Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle.”
The recall affects only specific lots of the medication. A full list is available here.
Teva advised patients to contact their pharmacy or prescribing healthcare provider for guidance and said it has sent recall letters with instructions for returning the affected products.