Mylan Pharmaceuticals Inc., is recalling more than 2.5 million bottles of generic Lipitor, a cholesterol-lowering statin medication known chemically as atorvastatin, due to the potential for microbial contamination. The Food and Drug Administration (FDA) has listed the issue as a Class II recall, which involves a situation in which use of or exposure to a violative product may cause temporary or medically reversible health consequences or where the probability of serious adverse health consequences is remote.
Affected products were distributed nationally. The recall includes atorvastatin calcium tablets packaged in 90-count or 500-count bottles and include more than 1.2 million 10mg tablets; 299,112 20mg tablets; 444,201 40mg tablets; and 452,269 80 mg tablets. The recall also affects 1,527 cartons of 10mg tablets packaged in 100-count bottles. Several lots are involved in the recall and the risk to patients is considered minimal.
Atorvastatin is a statin medication used to treat high cholesterol and triglyceride levels and may reduce the risk of angina, stroke, heart attack, and heart and blood vessel problems. Any adverse events realated to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Enforcement Report