More than 30,000 prescribed cholesterol drugs were recalled across the United States due to potency and dissolution issues, according to two separate recall notices published late last month by the Food and Drug Administration.
New Jersey-based Zydus Pharmaceuticals recalled 22,896 bottles of icosapent ethyl capsules in 120-count bottles in 1-gram doses, the FDA said in a notice. The recall was classified as Class II by the FDA on Jan. 22, it said.
The reason for the recall is due to sub-potency issues, the notice said.
“Due [to] oxidation caused by leakage of the contents” of the tablets, “use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients,” said the FDA.
The prescription-only drugs were manufactured by Softgel Healthcare Pvt. Ltd., based in India, and the drugs were distributed in the United States by Zydus Pharmaceuticals.
Icosapent ethyl, sometimes sold under the Vascepa brand, is a prescription-only omega-3 fatty acid that is used to lower high triglycerides and reduce cardiovascular disease risk, says the Mayo Clinic.
A recall issued by drug company AvKare involved 7,991 50-tablet cartons of 10-milligram rosuvastatin is under recall, according to an FDA notice, which said that the action was classified as a Class II recall on Jan. 20.
The reason for the recall, the FDA said, is due to the drug being “out of specification for dissolution,” which means that it has failed to meet an established acceptance criteria during quality testing.
Rosuvastatin, which is commonly branded as Crestor, is a heavily prescribed statin drug used to lower LDL cholesterol and triglycerides while raising beneficial HDL cholesterol, according to the Mayo Clinic.
Drug database website ClinCalc says it’s the 12th most commonly prescribed medication in the United States, with more than 42 million prescriptions filled for more than 11 million users in 2023. Icosapent ethyl was the 244th most prescribed drug in the United States that year.
A Class II recall is defined by the FDA as a situation where a product or drug “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
