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.
Recall initiated: 20150824
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated