Generic makers earn their livings off of volume, so when manufacturing issues lead to a recall, it can sometimes mean big numbers. That is the case with Mylan, which recently began the recall of more than 4 million bottles of cholesterol fighter atorvastatin because some of the tablets might be contaminated.
On March 20, the company began recalling 90 lots of the drug in dose sizes ranging from 10 mg to 80 mg. The FDA posted the recall as a class II on Tuesday.
Mylan said it was recalling the 4,005,177 bottles and 1,527 cartons because of the “potential of an elevated bioburden with identification of objectionable organisms.” The atorvastatin was manufactured at its plant in Morgantown, West Virginia.
Last fall, the drugmaker recalled more than 100,000 boxes and blister cards of its generic of seizure drug Klonopin that were manufactured at the Morgantown plant. They had been found to be out of specification for an impurity at the 16-month stability testing period.
Not all of its recalls, however, have involved big numbers. In January, Mylan recalled 4,191 bottles of temozolomide capsules, a generic of Merck & Co.’s chemo drug Temodar. The drug is used to treat newly diagnosed glioblastoma, a form of malignant brain tumor. That recall came after Mylan received customer complaints that some of the bottles contained broken or crushed capsules and loose powder in the bottles. They were also manufactured at the West Virginia plant.