Thousands of bottles of bisoprolol fumarate and hydrochlorothiazide tablets, commonly marketed under the brand name Ziac, have been recalled due to potential contamination concerns. Glenmark Pharmaceuticals Inc., based in Elmwood Park, New Jersey, announced the recall after tests indicated that some tablets may have been cross-contaminated with ezetimibe, a cholesterol medication also produced by the company.
The U.S. Food and Drug Administration (FDA), which oversees drug safety, classified the recall as Class III, indicating that exposure to the affected product is unlikely to lead to any serious health consequences. Bisoprolol/hydrochlorothiazide is often prescribed to manage hypertension by blocking beta-1 receptors in the heart, thus regulating heartbeats. The medication also promotes increased urination, which helps eliminate excess sodium and water from the body. This combination contributes to lower blood pressure, thereby reducing the risk of heart attacks and strokes.
The recall affects a range of tablet lots manufactured in Madhya Pradesh, India, for the U.S. market. The specific lots recalled include:
– 30-tablet bottles, NDC-68462-878-30: Lot 17232401, expiring 11/2025
– 100-tablet bottles, NDC-68462-878-01: Lot 17232401, expiring 11/2025
– 500-tablet bottles, NDC-68462-878-05: Lots 17232401, expiring 11/2025, and 17240974, expiring 05/2026.
As of now, Glenmark Pharmaceuticals has not provided specific guidance on the disposal of the recalled tablets. However, it is recommended for individuals who may have purchased these medications to check the lot numbers on their bottles. They should then contact their pharmacist or healthcare provider for further advice and properly discard any affected products.
This recall serves as a reminder for patients on prescribed medications to remain vigilant about checking for any recall notices, as safety standards in drug manufacturing are essential for their health and well-being.
