The Epoch Times – Thousands of units of a prescription medication used to treat high blood pressure were recently recalled and classified by the Food and Drug Administration (FDA) because of contamination, according to a notice issued by the agency on Dec. 1.
In a report published on Dec. 1 on the FDA’s website, more than 11,100 bottles of bisoprolol fumarate and hydrochlorothiazide tablets, USP, were recalled.
“Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications …”
The reason for the recall is “cross contamination with other products” after “testing of reserve samples showed presence of traces of ezetimibe,” the FDA notice said. Ezetimibe is a prescription drug used to lower high blood cholesterol.
Bisoprolol fumarate, a beta blocker that slows the heart rate by relaxing blood vessels, is combined with hydrochlorothiazide, a diuretic, to more effectively treat high blood pressure than bisoprolol alone. Ezetimibe is a cholesterol absorption inhibitor.
According to the FDA notice, the recalled bisoprolol fumarate and hydrochlorothiazide tablets are in 2.5-milligram/6.25-milligram strength doses in 30-count bottles with the code NDC-68462-878-30; in 100-count bottles with the code NDC-68462-878-01; or in 500-count bottles with the code NDC-68462-878-05.
“The FDA issued a warning letter to Glenmark earlier this year regarding the same Indian factory … “
They are from lot 17232401 with an expiration date of November 2025 as well as lot 17232401 with an expiration date of May 2026, according to the notice.
The drug was manufactured by Glenmark Pharmaceuticals Limited, located in Pithampur, Madhya Pradesh, India, the notice said. It was manufactured for Glenmark Pharmaceuticals, Inc., based in Mahwah, New Jersey …
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