Tens of thousands of bottles of cholesterol medication have been recalled nationwide.
Zydus Pharmaceuticals (USA) Inc. and AvKARE have recalled their respective medications over manufacturing and quality issues that could impact the drug’s potency, according to two separate releases from the Food and Drug Administration (FDA).
Zydus Pharmaceuticals is recalling approximately 22,896 bottles of Icosapent Ethyl capsules. The medication, manufactured by Softgel Healthcare and distributed in 120-count bottles, was classified as a subpotent drug.
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Oxidation caused by leaking capsules reduced the drug’s strength, federal officials warned. In turn, using the medication “may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” the recall notice read.
FDA classified the recall as Class II, meaning the products involved in the recall “might cause temporary, medically reversible health problems.” Serious consequences are also considered “remote.”
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AvKARE also recalled thousands of bottles of Rosuvastatin Tablets, packaged in 50-tablet unit dose cartons, according to a separate notice.
The medicine, according to federal officials, doesn’t dissolve the way it’s supposed to once you take it.
FDA also classified this recall as Class II.
Both recalls are still considered ongoing.
