Mylan has issued a voluntary Class II recall of 2,428,689 bottles and 1,527 cartons of atorvastatin calcium tablets, the generic version of Pfizer’s anti-cholesterol drug, Lipitor (atorvastatin), due to microbial contamination. Mylan initiated the recall in March 2017 based on microbial contamination of non-sterile products where there is potential of an elevated bioburden with the identification of objectionable organisms. The US Food and Drug Administration noted the recall on its website on March 28, 2017.
A Class II recall is a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Mylan’s recall applies to 1,233,107 bottles of the 10-mg tablets, 452,269 bottles of the 80-mg dosage tablets, 444,201 bottles of the 40-mg tablets, and 299,112 bottles of the 20-mg tablets in addition to the 1,527 cartons of the 10-mg tablets. The recall applies to atorvastatin calcium tablets packaged at Mylan’s facility in Morgantown, West Virginia.
Source: Food and Drug Administration: 10 mg bottles, 20 mg bottles, 40 mg bottles, 80 mg bottles, and 10 mg cartons