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: 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.

Code information: Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17

Distribution pattern: Nationwide, Puerto Rico, and Barbados