Recall: D-0484-2021

Class II - Potentially Harmful

Class IIClassification

2021-03-15Initiated

TerminatedStatus

Cardinal Health Inc.Firm

Product

EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

Reason

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.