Two lots of Quinapril and hydrochlorothiazide tablets, used to regulate blood pressure, have been recalled because of the presence of nitrosamines, the Food and Drug Administration posted on their website.
Nitrosamines are mostly seen in water and foods, including cured and grilled meats, dairy items, and vegetables. They heightened the risk of cancer if individuals are exposed to it at high levels over an extended period of time.
The pink, round tablets have 20 milligrams of quanapril and 12.5 milligrams of hydrochlorothiazide and are supplied in 90-count bottles that have an expiration date of January 2023.
In May 2021, Aurobindo Pharma USA, Inc., based in East Windsor, New Jersey, sent the now-recalled batches, identified as QE2021005-A and QE2021010-A, to customers in the country. As of now, the company hasn’t gotten any reports of adverse events connected to the recall.
Aurobindo is teaming up with Qualanex to manage the return of the recalled lots. Qualanex will reach out to its distributors and customers by phone and by letter to immediately halt the distribution of the recalled lots.
“Patients should contact their doctor or health care provider about whether to continue taking their medication or whether to consider an alternative treatment prior to returning their medication,” the FDA advisory notes.
Consumers should also reach out to their doctors or health care providers if they suffer any issues that may be connected to taking or using the drug.
Medical questions can be answered by calling Aurobindo at 1-866-850-2876 or by email at pvg@aurobindousa.com. Questions about the return of the recalled product can be directed to Qualanex at 1-888-504-2014.
Adverse reactions or quality problems experienced with the use of the drug may be sent to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax at 1-800-FDA-0178.
