Teva Pharmaceuticals has initiated a voluntary recall of more than 580,000 bottles of its Prazosin Hydrochloride capsules, a medication commonly prescribed for high blood pressure. The action was taken after testing by the U.S. Food and Drug Administration (FDA) revealed elevated concentrations of a chemical impurity linked to potential cancer risk. The recall, formally issued on October 7, concerns 1 mg, 2 mg, and 5 mg Prazosin capsules distributed across the nation, which were found to contain levels of the N-nitroso Prazosin impurity C that exceeded "acceptable intake limits," reports The WP Times.
Prazosin, widely known by the brand name Minipress, functions as an alpha-blocker and is used primarily to manage hypertension (high blood pressure), according to information provided by the Cleveland Clinic. Last week, the FDA categorized this action as a Class II recall. This classification signifies that while the use of the drug may potentially cause temporary or medically reversible adverse health consequences, the probability of serious, permanent harm is deemed low.
According to a memorandum released by the California Board of Pharmacy, Teva USA’s internal Health Hazard Assessment classified the overall risk to patients as medium. Despite the recall, the company confirmed as of Thursday that it had not received any "relevant complaints" directly related to the affected product lots. A company spokesperson issued a statement to NBC Chicago, emphasizing that "Prazosin is indicated for the treatment of hypertension, to lower blood pressure, and there are many alternative treatments available to patients." The spokesperson further added: "Teva prioritizes patient safety and product quality at every stage of a medicine’s lifecycle."
The recall is specifically limited to certain production lots of the medication. Teva advised all affected patients to immediately contact their dispensing pharmacy or prescribing healthcare provider for professional guidance on alternative treatments. Furthermore, the pharmaceutical manufacturer confirmed that recall letters containing comprehensive instructions for the return of the affected products have already been dispatched.
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