Bromfenac Ophthalmic Solution 0 recalled over manufacturing violations

Recall date

February 12, 2015

Source

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

Official notice title

Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle,…

Recall number

D-0487-2015

FDA classification

Class III

Brand / firm

Apotex Inc.

Sold / distributed

U.S. Nationwide.

Why it was recalled

CGMP Deviations: Product excipient was not re-tested at the appropriate date.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.