Thousands of bottles of the commonly prescribed blood pressure medication Ziac (bisoprolol fumarate and hydrochlorothiazide) have been voluntarily recalled by Glenmark Pharmaceuticals due to potential cross-contamination with ezetimibe, a cholesterol-lowering drug. The recall, classified as Class III by the FDA, indicates that exposure to the violative product is not likely to cause adverse health consequences. However, patients are advised to take precautions.
Key Takeaways
- Glenmark Pharmaceuticals has recalled over 11,100 bottles of Ziac.
- The recall is due to potential cross-contamination with ezetimibe, a cholesterol medication.
- The FDA has classified this as a Class III recall, suggesting low risk of adverse health effects.
- Affected lot numbers have expiration dates ranging from November 2025 to May 2026.
Details of the Recall
Glenmark Pharmaceuticals initiated the recall after testing reserve samples revealed the presence of trace amounts of ezetimibe, a drug the company also manufactures. The affected medication is bisoprolol fumarate and hydrochlorothiazide tablets, sold under the brand name Ziac. The recall encompasses multiple lots across various bottle sizes, including 30-count, 100-count, and 500-count bottles.
The specific lot numbers involved in the recall are:
- Lot 17232401, expiring November 2025
- Lot 17240974, expiring May 2026
These recalled tablets are available in 2.5 mg and 6.25 mg dosages and were manufactured in Madhya Pradesh, India, for Glenmark Pharmaceuticals, Inc., USA.
Understanding the Risk
The U.S. Food and Drug Administration (FDA) has categorized this recall as a Class III event. This classification signifies that the use of or exposure to the recalled product is not expected to cause serious adverse health consequences. Bisoprolol, combined with hydrochlorothiazide, works by blocking beta-1 receptors in the heart to regulate heart rate and by increasing urination to remove excess sodium and water, thereby lowering blood pressure and reducing the risk of heart attack and stroke.
What Patients Should Do
While the FDA and Glenmark Pharmaceuticals have not yet issued specific guidance on how consumers should handle the recalled medication, general advice for drug recalls suggests patients should check the lot number on their medication. If their medication is part of the recall, they are advised to contact their pharmacist and the healthcare provider who prescribed the drug. It is also recommended to safely dispose of any recalled medication.