New recall includes nearly 23K bottles of triglycerides drug used to treat heart disease
Zydus Pharmaceuticals, a New Jersey-based distributor of generic drugs, has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. The prescription-strength capsules were manufactured by Softgel Healthcare in India and are sold in the United States as a more affordable option to name-brand treatment options.
Icosapent ethyl is primarily used to help treat patients with high triglyceride levels in their blood. Taken together with a statin, it can also help significantly reduce the risk of heart attack, stroke or other cardiac complications in certain patient populations.
“Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” according to the Food and Drug Administration (FDA).
The FDA has ruled that this is a Class II recall, which means taking the drug could cause “temporary or medically reversible adverse health consequences.” The bottles in question contain 120 capsules. This recall only covers icosapent ethyl capsules distributed by Zydus Pharmaceuticals; other versions of the drug, including the Vascepa capsules sold by Amarin, are not affected in any way.
Zydus Pharmaceuticals, founded in 2005, is one of the largest distributors of generic drugs in the United States. Its parent company is Zydus Lifesciences Limited, a large healthcare provider based out of India.
Click here for more information from the FDA about this Class II recall.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.