FDA Recalls Blood Pressure Medicine Tainted with Cancer-Causing Chemical
- Earlier this month, New Jersey-based Teva Pharmaceuticals USA voluntarily recalled certain prazosin hydrochloride capsules, and the FDA classified the recall as Class II last week covering more than 580,000 bottles nationwide.
- Regulators say testing found N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach acceptable intake limit, which can form during manufacture or storage and is potentially carcinogenic.
- The recall lists specific lot details and counts, noting that 181,659 bottles of Prazosin Hydrochloride, 1 mg capsules, 291,512 bottles of 2 mg, and 107,673 bottles of 5 mg are affected, all sold in 100, 500, and 1,000 capsule bottle sizes.
- The FDA and pharmacists recommend that patients prescribed prazosin check lot numbers, consult their pharmacists and prescribers, and note the FDA warns prolonged nitrosamine exposure may raise cancer risk.
- High blood pressure affects nearly 119.9 million U.S. adults, and other manufacturers like Pfizer and Merck have also reported nitrosamine impurities, reflecting a wider industry issue.
235 Articles
235 Articles
FDA Announces Recall of Blood Pressure Drug Due to Cancer Risk.
PULSE POINTSWHAT HAPPENED: Over 580,000 bottles of prazosin hydrochloride, a blood pressure medication, were recalled due to potential contamination with a cancer-causing chemical.WHO WAS INVOLVED: Teva Pharmaceuticals USA, Amerisource Health Services, and the Food and Drug Administration (FDA).WHEN & WHERE: Nationwide recall issued earlier this month by New Jersey-based Teva Pharmaceuticals and Amerisource Health Services.IMPACT: The recall aff…
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