The U.S. Food and Drug Administration (FDA) on Thursday confirmed the recall of tens of thousands of bottles of a medication prescribed to treat high cholesterol.
In an enforcement
report, the agency said that 57,504 bottles of 2-milligram pitavastatin tablets were voluntarily recalled by the manufacturer due to “failed impurities” or “degradation specifications,” which are terms used in the pharmaceutical industry to indicate that a drug or substance doesn’t meet the required quality standards.
Each bottle of the drug
contains 90 tablets. The manufacturer is Taiwan-based Orient Pharma Co., Ltd., for New Jersey-based Teva Pharmaceuticals, according to the FDA.
The recall was initiated by the company last month but the FDA on Thursday only issued its classification of the recall as Class III, the least severe type of recall under FDA
guidelines. It
means that a product violates agency regulations but is unlikely to cause serious adverse health consequences.
It’s not clear from the FDA report whether any adverse effects were reported in association with the recall. More details about why the recall was initiated were not provided in the report.
Pitavastatin is in the statin family,
which is associated with brand names such as Livalo and Zypitama. Statins are a class of prescription drugs primarily used to lower cholesterol, associated with a reduction in the risk of heart attack or stroke.
The Cleveland Clinic says pitavastatin “helps you lower the amount of ‘bad’ cholesterol” known as LDL, or low-density lipoprotein, in a person’s blood. The drug “interferes with your liver’s process of making cholesterol, which makes it produce less of it,” the clinic says.
The drug is also used increase the body’s amount of high-density lipoprotein (HDL) cholesterol in adults, says a
description on the federal MedicinePlus website
According to the National Institutes of Health,
approximately 92 million Americans were taking a type of statin drug between 2018 and 2019, it said, compared to 37 million who were taking them in 2012 and 2013.
Earlier this year, in separate incidents, two other types of drugs used to treat high cholesterol were recalled, according to FDA
enforcement reports.
In March, 2,184 bottles of Atorvastatin Calcium Tablets by drug company Biocon Pharma Inc. were recalled for “failed dissolution specifications,” said the FDA. In April, the FDA updated a recall of 5,328 bottles of Livalo, which is the brand name for pitavastatin due to the “presence of foreign tablets/capsules,” the agency noted said.
The recall comes after another company, Glenmark Pharmaceuticals Inc., voluntarily recalled dozens of types of generic medications after FDA regulators found problems in how the medications were being manufactured at one of its India-based facilities, said an FDA enforcement
report in April.
