Atorvastatin recall affects over 140,000 cholesterol medication bottles

Federal well being officers are advising customers that greater than 140,000 bottles of ldl cholesterol medicines are being recalled as a result of “failed dissolution specs.”

A number of bottle sizes of Atorvastatin Calcium Tablets, 10 mg (prescription solely), a drug used to decrease ldl cholesterol and assist forestall coronary heart illness, coronary heart assault and stroke, are affected by the recall, the Meals and Drug Administration (FDA) mentioned in an enforcement report.

Atorvastatin Calcium tablets are the generic type of Lipitor and belong to the group referred to as statins. It really works by blocking an enzyme within the liver that impacts the physique used to make cholesterol.

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Atorvastatin Calcium Tablets are the generic type of Lipitor. (George Frey/Bloomberg by way of Getty Photos)

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If a drug “doesn’t meet troubleshooting specs,” it signifies that the drug doesn’t dissolve in laboratory assessments because it ought to in response to official requirements. If a tablet doesn’t dissolve correctly, the drug could not work as successfully to regulate levels of cholesterol.

A pharmacist removes a medicine from a shelf in a pharmacy in Provo, Utah. (George Frey/Bloomberg by way of Getty Photos)

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Numerous bottle sizes of Atorvastatin Calcium Tablets, 10 mg (prescription solely) are topic to the recall. (Joe Raedle/Getty Photos)

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The warning is taken into account a Class II recall, which is when use or publicity to a product “could trigger short-term or medically reversible hostile well being results or the place the probability of great hostile well being results is distant,” in response to the FDA’s web site.

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The drug was manufactured by Alkem Laboratories and distributed by Ascend Laboratories LLC.

Eight lot numbers are affected with expiration dates starting from July 2026 to February 2027. Bottle sizes embody 90 tablets, 500 tablets and 1,000 tablets.

FOX Enterprise contacted Alkem Laboratories and Ascend Laboratories for remark.