Bromfenac Ophthalmic Solution 0 recalled over sterility concerns

Recall date

August 25, 2015

Source

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

Official notice title

Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596…

Recall number

D-0009-2016

FDA classification

Class II

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: Failed preservative effectiveness testing

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%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.