www.fdanews.com/articles/176340-impax-pulls-35m-cholesterol-capsules-over-incorrect-labeling
Impax Pulls 35M Cholesterol Capsules Over Incorrect Labeling
April 25, 2016
Impax Laboratories and a unit of AmerisourceBergen have initiated two recalls of fenofibrate cholesterol drugs due to incorrect labeling.
The nationwide recalls, initiated last March, were deemed Class 2 last week. The affect 21 lots, according to an April 14 FDA Enforcement Report. The recall affects the 500- and 134-mg dosages.
Approximately 35 million capsules are involved in the recall.