FDA-Drug2015-09-30Class II
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.
Allergan Sales, LLC
Hazard
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.
Sold states
Nationwide, Puerto Rico, and Barbados
Affected count
28,292 tubes
Manufactured in
8301 Mars Dr, N/A, Waco, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1819-2015Don't want to check this manually?
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