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FDA recalls blood pressure medication due to contamination concerns
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The U.S. Food and Drug Administration (FDA) issued a nationwide recall of thousands of bottles of blood-pressure medication last week after discovering cross-contamination with another drug.
Federal regulators issued the warning on Dec. 1 for roughly 11,100 bottles of the combination medication bisoprolol fumarate and hydrochlorothiazide, sold under the brand name Ziac.
Testing revealed that “trace amounts of ezetimibe,” a prescription drug used to treat high cholesterol, were detected in reserve samples.
The recall was classified as Class III, indicating that use of or exposure to the contaminated product is “not likely to cause adverse health consequences,” according to the agency.
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High blood pressure tablets exit a machine on April 9, 2014. (Krisztian Bocsi/Bloomberg / Getty Images)
Glenmark Pharmaceuticals, based in Elmwood Park, New Jersey, manufactures both the recalled blood-pressure tablets and ezetimibe.
The affected pills come in 2.5-milligram and 6.25-milligram doses, according to federal regulators.
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In this photo illustration, the Glenmark Pharmaceuticals company logo is seen displayed on a smartphone screen. (Piotr Swat/SOPA Images/LightRocket / Getty Images)
The FDA added that the recall affects 30-count bottles (NDC 68462-878-30), 100-count bottles (NDC 68462-878-01) and 500-count bottles (NDC 68462-878-05).
The recalled lot numbers carry expiration dates ranging from November 2025 to May 2026, the agency said.
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A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland. (Sarah Silbiger/Getty Images / Getty Images)
Bisoprolol fumarate and hydrochlorothiazide are commonly prescribed together, according to Mayo Clinic. Bisoprolol helps the heart beat more regularly, while hydrochlorothiazide increases urination to remove excess sodium and water. Combined, the drugs help relax blood vessels, lower blood pressure, and reduce the risk of heart attacks and strokes.
Glenmark Pharmaceuticals and the FDA did not immediately respond to a request for comment from FOX Business.
