Health and Me

Ishita Roy

FDA Recalls High Blood Pressure Medication, Here's Why

A commonly prescribed blood pressure medication is being pulled from shelves after routine testing revealed possible contamination with another drug. Glenmark Pharmaceuticals Inc., which has its U.S. headquarters in Elmwood Park, New Jersey, has voluntarily recalled more than eleven thousand bottles of bisoprolol fumarate and hydrochlorothiazide tablets, sold under the brand name Ziac. The recall was announced in an online report published by the U.S. Food and Drug Administration.

According to the FDA, reserve sample testing detected traces of ezetimibe, a medication used to treat high cholesterol. Glenmark manufactures both drugs, and officials say the presence of ezetimibe suggests the tablets may have been cross contaminated during production. The recall affects the 2.5 milligram and 6.25 milligram strengths of the medication, which is used to treat hypertension by helping the heart beat more normally, reducing fluid retention and relaxing blood vessels.

The recall has been classified as Class III, which is the lowest risk category. This means that although the product violates FDA standards, the agency does not expect the contaminated tablets to pose serious or immediate health risks. Class III recalls generally involve issues that are unlikely to cause adverse health consequences. However, the FDA still requires the manufacturer to remove the affected lots from circulation.

The recall covers several bottle sizes packaged for the U.S. market. The affected National Drug Codes are:

<ul><li>30 count bottles, NDC 68462 878 30</li><li>100 count bottles, NDC 68462 878 01</li><li>500 count bottles, NDC 68462 878 05</li></ul>

According to the FDA report, the impacted lots include Lot 17232401, which has an expiration date of November 2025, and Lot 17240974, which expires in May 2026. The tablets were manufactured in Madhya Pradesh, India for Glenmark’s U.S. division. In total, more than eleven thousand bottles are part of the recall.

Neither Glenmark Pharmaceuticals nor the FDA has issued specific instructions for patients who may have the recalled medication at home. However, standard guidance from GoodRx and other pharmacy resources advises patients to take a few simple steps. Individuals should check the lot number on their medication bottle and compare it with the recalled lots. If the numbers match, patients are encouraged to contact their pharmacist or prescriber to discuss next steps. Most pharmacists will recommend safely discarding the recalled medication and arranging for a replacement prescription.

While the contamination involves only trace amounts of another drug and is not expected to cause serious harm, health experts note that taking medication that has been compromised in any way is not advisable. Patients who rely on bisoprolol fumarate and hydrochlorothiazide for blood pressure control should not stop treatment abruptly without consulting their healthcare provider.

Bisoprolol and hydrochlorothiazide is a combination drug that lowers blood pressure by blocking beta 1 receptors in the heart, increasing urination to remove excess sodium and water, and relaxing blood vessels. It is commonly prescribed to reduce the risk of heart attacks and strokes in patients with hypertension.

With the recall in place, patients are encouraged to stay alert, review their medication labels and reach out to their healthcare team if they believe they have received an affected batch.

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A commonly prescribed blood pressure medication is being pulled from shelves after routine testing revealed possible contamination with another drug. Glenmark Pharmaceuticals Inc., which has its U.S. headquarters in Elmwood Park, New Jersey, has voluntarily recalled more than eleven thousand bottles of bisoprolol fumarate and hydrochlorothiazide tablets, sold under the brand name Ziac. The recall was announced in an online report published by the U.S. Food and Drug Administration.Why the Drug Was RecalledAccording to the FDA, reserve sample testing detected traces of ezetimibe, a medication used to treat high cholesterol. Glenmark manufactures both drugs, and officials say the presence of ezetimibe suggests the tablets may have been cross contaminated during production. The recall affects the 2.5 milligram and 6.25 milligram strengths of the medication, which is used to treat hypertension by helping the heart beat more normally, reducing fluid retention and relaxing blood vessels.The recall has been classified as Class III, which is the lowest risk category. This means that although the product violates FDA standards, the agency does not expect the contaminated tablets to pose serious or immediate health risks. Class III recalls generally involve issues that are unlikely to cause adverse health consequences. However, the FDA still requires the manufacturer to remove the affected lots from circulation.Products and Lots IncludedThe recall covers several bottle sizes packaged for the U.S. market. The affected National Drug Codes are:30 count bottles, NDC 68462 878 30100 count bottles, NDC 68462 878 01500 count bottles, NDC 68462 878 05According to the FDA report, the impacted lots include Lot 17232401, which has an expiration date of November 2025, and Lot 17240974, which expires in May 2026. The tablets were manufactured in Madhya Pradesh, India for Glenmark’s U.S. division. In total, more than eleven thousand bottles are part of the recall.What Patients Should KnowNeither Glenmark Pharmaceuticals nor the FDA has issued specific instructions for patients who may have the recalled medication at home. However, standard guidance from GoodRx and other pharmacy resources advises patients to take a few simple steps. Individuals should check the lot number on their medication bottle and compare it with the recalled lots. If the numbers match, patients are encouraged to contact their pharmacist or prescriber to discuss next steps. Most pharmacists will recommend safely discarding the recalled medication and arranging for a replacement prescription.While the contamination involves only trace amounts of another drug and is not expected to cause serious harm, health experts note that taking medication that has been compromised in any way is not advisable. Patients who rely on bisoprolol fumarate and hydrochlorothiazide for blood pressure control should not stop treatment abruptly without consulting their healthcare provider.Understanding the MedicationBisoprolol and hydrochlorothiazide is a combination drug that lowers blood pressure by blocking beta 1 receptors in the heart, increasing urination to remove excess sodium and water, and relaxing blood vessels. It is commonly prescribed to reduce the risk of heart attacks and strokes in patients with hypertension.With the recall in place, patients are encouraged to stay alert, review their medication labels and reach out to their healthcare team if they believe they have received an affected batch.