Blood Pressure Drug Recalled Over Cross-Contamination Concerns
A major recall has been issued for a widely used blood pressure medication due to cross-contamination concerns. Glenmark Pharmaceuticals Inc. is recalling over 11,100 bottles of bisoprolol fumarate and hydrochlorothiazide tablets, sold under the brand name Ziac.
Details of the Recall
The recall was officially announced on December 1, by the Food and Drug Administration (FDA). It has been categorized as a Class III recall, indicating that the exposure to the affected products is “not likely to cause adverse health consequences.”
Potential Cross-Contamination
- Testing of reserve samples revealed the presence of ezetimibe.
- Ezetimibe is a medication used for managing cholesterol levels.
Affected Product Information
The compromised medication is available in two different doses: 2.5mg and 6.25mg. The recall affects specific packages, which include:
- 30-count bottles (NDC-68462-878-30)
- 100-count bottles (NDC-68462-878-01)
- 500-count bottles (NDC-68462-878-05)
The impacted lot numbers have expiration dates ranging from November 2025 to May 2026. In total, 11,136 bottles are involved in this recall.
Usage of Bisoprolol and Hydrochlorothiazide
Bisoprolol and hydrochlorothiazide work together to manage high blood pressure by blocking beta-1 receptors in the heart, promoting a normal heartbeat.
Next Steps for Patients
The FDA has yet to provide guidance on what patients should do if their medication is included in this recall. Both the FDA and Glenmark Pharmaceuticals have been contacted for further comments regarding the situation.
