FDA recall D-0487-2015

Product

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.

Reason for recall

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

Distribution

U.S. Nationwide.

Key facts

Status

Terminated

Initiation date

2015-02-12

Report date

2015-04-22

Termination date

2016-12-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0487-2015