{"id":787291,"date":"2026-07-08T01:38:17","date_gmt":"2026-07-08T01:38:17","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/787291\/"},"modified":"2026-07-08T01:38:17","modified_gmt":"2026-07-08T01:38:17","slug":"cholesterol-drug-recall-at-national-level-gets-fda-ruling","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/787291\/","title":{"rendered":"Cholesterol Drug Recall at National Level Gets FDA Ruling"},"content":{"rendered":"

If you indulged more than usual over the holiday weekend, this week experts with the Mayo Clinic Diet<\/a> recommended meals that are high in protein<\/a> and pre- and probiotics to help your system reset. Meanwhile, if you\u2019re one of the greater than 92 million Americans taking medication to manage cholesterol, an extra layer of caution for your health may be warranted after the U.S. Food and Drug Administration (FDA) published a recall<\/a> on a cholesterol medication.<\/p>\n

A \u201cU.S. Nationwide\u201d recall began on May 8, according to a recent FDA report. New Jersey-based Ajanta Pharmaceuticals is said to have voluntarily initiated the event when \u201cCGMP deviations\u201d\u2014that is, \u201ccurrent good manufacturing practice\u201d according to regulatory standards\u2014appeared to have been violated or overlooked.<\/p>\n

The FDA<\/a> provides the following background on CGMP compliance:<\/p>\n

\u201cAdherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations \u2026 This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors.\u201d<\/p>\n

The present recall affects 100-count bottles of 200-milligram fenofibrate capsules, totaling 3,648 units manufactured by Ajanta Pharma Limited in India. Fenofibrate appears to be a generic alternative to what the Cleveland Clinic<\/a> suggests is the brand name Lipofen.<\/p>\n

The lot number of the recalled fenofibrate is reported as PA02216, with expiration of 12\/2029.<\/p>\n

The June 22 FDA report states the agency assigned the event as a Class II<\/a> recall, determined as its mid-level risk to consumer health where \u201ctemporary or medically reversible adverse health consequences\u201d are deemed plausible.<\/p>\n

Different from statins, which are taken by a reported 92 million Americans<\/a> as estimated in 2023, the Cleveland Clinic explains, \u201cFenofibrate is a medication that treats high cholesterol and triglyceride levels in your blood. It works by decreasing bad cholesterol and fats and increasing good cholesterol in your blood.\u201d<\/p>\n

For daily wellness updates, subscribe to The Healthy newsletter<\/a> and follow The Healthy on Facebook<\/a> and Instagram<\/a>. Keep reading:<\/p>\n

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