Aurobindo Pharma USA this week recalled quinapril and hydrochlorothiazide 20 mg./12.5 mg. combination tablets used to treat high blood pressure, also known as hypertension.
According to a U.S. Food and Drug Administration publication of the New Jersey company’s recall notice, the recall was due to impurities that may increase cancer risks.
Specifically, the medication was found to have a presence of “Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit,” per the release.
Aurobindo began shipping the subject batches of the pills to customers across the U.S. last May. These effected batches are QE2021005-A and QE2021010-A.
“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines,” the company explained. However, “these impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
As of Monday, Aurobindo Pharma USA, Inc. had not received any reports of adverse events related to the recall.
“Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide,” to lower patients’ blood pressure, said the company.
Patients with hypertension who do not control their blood pressure may be at increased risk for heart attacks, according to the Mayo Clinic.
“High blood pressure adds to the workload of the heart and arteries,” the clinic said. “If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure.”
Aurobindo’s recalled blood pressure medication comes in the form of light pink, round, scored pills embossed with a D on one side and the number 19 on the other. Patients who take Quinapril and Hydrochlorothiazide Tablets should contact their health care provider about whether to continue taking the pills.
“Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts,” said the company. “Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.”
Consumers can call Aurobindo Pharma USA with medical questions regarding the recall or to report an adverse event at 1-866-850-2876 (Option 2), 24 hours per day, seven days per week. They can also email pvg@aurobindousa.com or submit a report through the FDA.
Related
Related
