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) due to contamination, according to a notice issued by the agency on Dec. 1.
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 is a beta blocker, used to slow the heart rate by relaxing blood vessels. 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.
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.
Glenmark voluntarily initiated the recall last month, and the FDA classified the recall and posted the notice on Monday. The recall is ongoing and nationwide, the FDA said.
“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, whether or not the batch has already been distributed,” said the warning letter, which did not name any specific drugs that were manufactured at the factory.
