Over 140,000 bottles of a common cholesterol medication have been recalled because the pills “failed dissolution specifications,” meaning the drugs may not dissolve properly in the body once it’s swallowed.
Ascend Laboratories, a New Jersey-based pharmaceutical company, first initiated the recall of the Atorvastatin Calcium Tablet on Sept. 19, the Food and Drug Administration (FDA) announced.
The recalled drugs were categorized as a “Class II” recall meaning the product could “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the administration.
The recall only affects 10mg, 20mg, 40 mg and 80mg atorvastatin calcium tablets manufactured by Alkem Laboratories of India and distributed by Ascend. The recalled bottles contained different amounts of the pills ranging from 90-count to 1000-count bottles.
In total, 141,984 bottles of the 10mg medication were involved in the recall. The quantity of bottles containing 20mg, 40mg and 80mg pills were not mentioned in the report.
Since this recall is considered a “Class II” the FDA says it’s generally OK for customers to continue taking the medication unless the company provides other instructions.
“In some instances, stopping your medicine may be more harmful to your health than continuing to take the recalled medicine,” the administration explains. “Talk to your doctor or pharmacist if you have any questions or concerns about your medicine.”
Atorvastatin is used to decrease the amount of cholesterol and other fatty substances in the blood, helping to reduce the risk of heart attacks and strokes for people with or at risk of heart disease, according to Medline Plus. It is also prescribed to children and teenagers between 10 and 17 years old who have difficulty removing cholesterol normally.
Nearly 30 million people in the U.S. took Atorvastatin in 2023 and it was considered the most used drug, ClinCalc reports.
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