FDA recall D-1819-2015

Product

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.

Reason for recall

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Distribution

Nationwide, Puerto Rico, and Barbados

Key facts

Status

Terminated

Initiation date

2015-08-24

Report date

2015-09-30

Termination date

2017-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waco, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1819-2015