FDA recall D-0422-2019

Product

BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41

Reason for recall

Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-01-24

Report date

2019-02-06

Termination date

2021-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0422-2019