Thousands of cholesterol drug bottles recalled nationwide over manufacturing defects
- Regulator: FDA
- Classification: Class II
- Zydus Impact: ~22,896 Bottles
- Defect 1: Oxidation / Leaking
- Defect 2: Dissolution Failure
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), tens of thousands of bottles of cholesterol medication have been recalled nationwide.
Zydus Recall: Icosapent Ethyl
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.
Federal officials warned that oxidation caused by leaking capsules reduced the drug’s strength.
— Recall Notice
AvKARE Recall: Rosuvastatin Tablets
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 Classification: Class II
The FDA classified both recalls as Class II. This means the products involved in the recall "might cause temporary, medically reversible health problems." Serious consequences are also considered "remote."
