In a significant voluntary action, Glenmark Pharmaceuticals Inc. has pulled back thousands of bottles of a widely prescribed blood pressure medication from the American market. The recall was initiated after tests revealed the presence of traces of another drug, raising concerns about cross-contamination.
Details of the Glenmark Drug Recall
The affected product is Ziac (bisoprolol fumarate and hydrochlorothiazide tablets), a combination drug used to manage hypertension. The company's US headquarters in Elmwood Park, New Jersey, announced the recall of more than 11,100 bottles across three different pack sizes. The manufacturing for the US market was done at a facility in Madhya Pradesh, India, while the corporate headquarters of Glenmark are based in Mumbai.
The decision to recall was taken after laboratory analysis of reserve samples detected traces of ezetimibe, a medication primarily used to control high cholesterol levels. The US Food and Drug Administration (FDA) has been notified and has classified this event as a Class III recall. This classification indicates that the use of the contaminated product is unlikely to result in adverse health consequences, but the action is necessary to maintain quality standards.
How to Identify the Recalled Blood Pressure Medication
Consumers and pharmacists need to check the specific details on their medication bottles. The recall impacts Ziac in 2.5 mg/6.25 mg dosage strengths. The following lot numbers and their corresponding bottle sizes are involved:
- Lot No. 17232401 with expiration date 11/2025.
- Lot No. 17240974 with expiration date 05/2026.
The bottles can be identified by their National Drug Code (NDC):
- 30-tablet bottles: NDC-68462-878-30
- 100-tablet bottles: NDC-68462-878-01
- 500-tablet bottles: NDC-68462-878-05
What Should Patients Do Now?
As of now, neither Glenmark nor the FDA has issued specific instructions for consumers who possess the recalled lots. However, medical experts and platforms like GoodRx advise a cautious approach. Patients should not stop taking their blood pressure medication abruptly, as this can be dangerous.
The recommended steps are:
- Immediately check the bottle for the lot number and NDC to see if it matches the recalled batches.
- Contact your pharmacist to verify the information and discuss a replacement.
- Inform the healthcare provider who prescribed the medication about the recall.
- Properly dispose of the recalled medication as per local guidelines once a safe alternative is secured.
Ziac works by blocking beta-1 receptors in the heart to normalize heart rate and by promoting urination to remove excess sodium and water. This dual action helps relax blood vessels, lower blood pressure, and reduce the risk of heart attacks and strokes. Patients are urged to consult their doctor for any concerns and never to change their treatment regimen without professional medical advice.
