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Federal well being officers are advising customers that greater than 140,000 bottles of ldl cholesterol remedy are being recalled as a result of “failed dissolution specs.”
A number of bottle sizes of Atorvastatin Calcium Tablets, 10-mg (Prescription Solely), a medication used to decrease ldl cholesterol and assist stop coronary heart illness, coronary heart assaults and strokes, are impacted by the recall, the Meals and Drug Administration (FDA) stated in an enforcement report.
Atorvastatin Calcium Tablets are the generic type of Lipitor and is a medication from a gaggle referred to as statins. It really works by blocking an enzyme within the liver that the physique makes use of to make ldl cholesterol.
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Atorvastatin Calcium Tablets are the generic type of Lipitor. (George Frey/Bloomberg through Getty Photographs)
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If a drugs has “failed dissolution specs,” it means the drug didn’t dissolve in laboratory testing the best way it’s presupposed to in keeping with official requirements. If a tablet doesn’t dissolve the best way it ought to, the drugs won’t work as successfully to regulate levels of cholesterol.
A pharmacist pulls a drug from a shelf inside a pharmacy in Provo, Utah. (George Frey/Bloomberg through Getty Photographs)
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A number of bottle sizes of Atorvastatin Calcium Tablets, 10-mg (Prescription Solely) are impacted by the recall. (Joe Raedle/Getty Photographs)
The alert is taken into account a Class II recall, which is when the use or publicity to a product “could trigger non permanent or medically reversible opposed well being penalties or the place the likelihood of significant opposed well being penalties is distant,” in keeping with the FDA’s web site.
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The remedy was manufactured by Alkem Laboratories and distributed by Ascend Laboratories LLC.
There are eight lot numbers impacted with expiration dates ranging between July 2026 to February 2027. The bottle sizes included 90 tablets, 500 tablets and 1,000 tablets.
FOX Enterprise reached out to Alkem Laboratories and Ascend Laboratories for remark.