Recall: D-0413-2021

Class II - Potentially Harmful

Class IIClassification

2021-03-15Initiated

TerminatedStatus

Cardinal Health Inc.Firm

Product

BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS

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.