FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Postmarket Safety

Impax Pulls 35M Cholesterol Capsules Over Incorrect Labeling

April 26, 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.


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