FDA-Drug2015-08-26Class II

Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

Bausch & Lomb, Inc.
Hazard

Lack of Assurance of Sterility: Failed preservative effectiveness testing.

Sold states
U.S. Nationwide and Puerto Rico
Affected count
13,995 Bottles
Manufactured in
8500 Hidden River Pkwy, Tampa, FL, United States
Products
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1349-2015

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