Camilla Jessen
The recall involves tens of thousands of bottles distributed nationwide.
Patients across the United States are being urged to check their prescriptions after a problem was identified with a widely used heart medication.
According to the U.S. Food & Drug Administration, 22,896 bottles of a prescription cholesterol medication have been recalled across the country. The action was taken after a chemical issue was discovered during quality checks.
The FDA said the recall applies to 120-count bottles of Icosapent Ethyl manufactured by Softgel Healthcare and distributed by Zydus Pharmaceuticals.
Medication details
Icosapent Ethyl is commonly prescribed alongside statins to lower high triglyceride levels and reduce the risk of serious cardiovascular events, including heart attacks.
The FDA said the affected products were identified by specific lot numbers and expiration dates.
These include lot codes “S2520304” and “S2520333” with an expiration date of “2/28/2027,” as well as lot code “S2540186” with an expiration date of “4/30/2027.”
Reason for recall
The recall was announced after an oxidation issue was detected.
According to the FDA, the problem was caused by “leakage of the contents of the Icosapent Ethyl capsules.”
In a notice, the agency said that “use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.”
Health risk level
The FDA has classified the recall as Class II. This category is used when a product may cause temporary or medically reversible health effects, with a low probability of serious harm.
Patients who have taken the recalled medication are advised to contact a healthcare provider if they have any medical concerns.
Consumers who have the affected lot numbers are advised to stop using the medication and either dispose of it or return it to their pharmacy for a possible refund or replacement.
For further information, the FDA said patients can call 1-888-INFO-FDA (1-888-463-6332).
Sources: U.S. Food & Drug Administration
