Allergan Sales, LLC recalls FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04…

Recall date

August 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1819-2015

FDA classification

Class II

Brand / firm

Allergan Sales, LLC

Sold / distributed

Nationwide, Puerto Rico, and Barbados

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.