FDA recall D-1349-2015

Bausch & Lomb, Inc. · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing.

Distribution

U.S. Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-08-17
Report date: 2015-08-26
Termination date: 2017-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tampa, FL, United States

Primary source

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