FDA recall D-0009-2016

Apotex Inc. · Class II · drug

Product

Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.

Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-08-25
Report date: 2015-10-21
Termination date: 2022-06-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2016