Bromfenac Ophthalmic Solution 0 recalled over sterility concerns

Recall date

January 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mayne Pharma Usa recalls Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx o…

Recall number

D-0585-2016

FDA classification

Class II

Brand / firm

Mayne Pharma Usa

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: Failed preservative effectiveness test

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505