A blood pressure medication was recalled after the wrong pills were found in a bottle.
This is just a few weeks after several blood pressure drugs were recalled due to an “unexpected” impurity.
On Monday, Aurobindo Pharma USA Inc. announced it is taking off store shelves 80 lots of its Amlodipine Valsartan, Valsartan HCTZ, and Valsartan tablets.
The company said it hasn’t received any reports yet of adverse patient reactions to their products.
However, the tablets contain the chemical N-nitrosodiethylamine (NDEA),
which the Food and Drug Administration (FDA) has classified as a “probably human carcinogen.”
The Aurobindo announcement was the latest in a series of recalls of medications designed to treat high blood pressure.
The recall announcements began in late July.
Last month, officials at Mylan said the pharmaceutical company would recall all lots of its blood pressure medication valsartan.
The additional 104 lots were being taken off shelves “out of an abundance” of caution, company officials said, because of reports that valsartan products may contain traces of a potential cancer-causing impurity.
The previoius week, Teva Pharmaceuticals announced they were voluntarily recalling two blood pressure medications due to an impurity that has been detected above “specification limits.”
The Teva products are Amlodipine/Valsartan combination tablets and Amlodipiine/Valsartan/Hydrochlorothiazide tablets
Company officials urged people who use the tablets to continue taking the medication and consult with their doctor about potential alternative treatments. They said the potential harm of stopping their medication was higher than the potential risk from the tablets.
In late October, officials at the FDA announced they were adding a brand of drugs sold under the RemedyRepack to the list of medications recalled due to the ingredient in question.
The 100-pill bottle was supposed to have Hydrochlorothiazide Tablets USP 12.5 mg. Instead, it was filled with Spironolactone Tablets USP 25 mg. That medication is used to treat congestive heart failure and cirrhosis of the liver, among other ailments.
FDA officials told USA Today that the effects of taking this incorrect medication range from “limited” to “life threatening,” depending on the individual.
That news came just a few weeks after the FDA expanded an initial recall involving drugs containing valsartan, which is used to treat high blood pressure and heart failure.
In early August, FDA officials announced they had updated the list of drugs affected by the recall, which was originally announced in July. They also noted the recall is now a worldwide recommendation.
Multiple companies voluntarily recalled their medications, including valsartan from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd., as well as valsartan/hydrochlorothiazide from Solco and Teva.
What should patients do?
The FDA lists recall instructions provided by the specific companies, including the drug lot numbers included in the recall and how to return or dispose of the affected medicines.
It noted that patients should look at the name of the drug and company listed on the prescription label to determine if their medication has been recalled. They can also contact the pharmacy where they picked it up.
These medications are used to treat serious medical conditions — high blood pressure and heart failure.