Recall -- Firm Press Release
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Allergan Issues Voluntary Nationwide Recall In The U.S. Of Specific Lots Of REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1%, and Blephamide® (Sulfacetamide Sodium And Prednisolone Acetate Ophthalmic Ointment, USP) 10%/0.2% For Particulate Matter
FOR IMMEDIATE RELEASE - Dublin, Ireland – August 24, 2015 – Allergan plc, today announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH® Lacri-Lube® 3.5g and 7g for dry eye, REFRESH P.M.® 3.5g for dry eye, FML® (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.
Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product. Reported adverse events include Foreign Body in Eye (12), Eye Irritation (2), Ocular Discomfort (2), Product Contamination (2), Superficial Injury of Eye (2), Eye Pain (1), Eye Swelling (1) and Vision Blurred (1).
Specific lots are being voluntarily recalled in the interest of patient safety. If the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation. Please contact your physician or healthcare provider if you have any of these symptoms when using these products. The lot number and expiration date may be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube.
Specific information on product and lots that are being voluntarily recalled are below
|NDC||Description||Lot Number||Expiration Date|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||84746||Apr-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||84987||May-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||85087||May-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||85359||Jun-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||85721||Jul-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||86045||Aug-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||86406||Sep-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||86594||Oct-17|
|0023-0312-04||REFRESH® Lacri-Lube® 3.5 g||87021||Nov-17|
|0023-0312-07||REFRESH® Lacri-Lube® 7g||86470||Sep-17|
|0023-0312-07||REFRESH® Lacri-Lube® 7g||86829||Oct-17|
|0023-0312-07||REFRESH® Lacri-Lube® 7g||87105||Nov-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85165||May-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85228||May-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85244||Jun-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85351||Jun-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85374||Jun-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85397||Jun-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85561||Jul-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85676||Jul-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85694||Jul-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85834||Aug-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85977||Aug-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85985||Aug-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86073||Aug-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||85599||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86290||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86325||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86411||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86427||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86506||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86515||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86517||Sep-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86746||Oct-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86792||Oct-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86789||Oct-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86809||Oct-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86822||Oct-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86822A||Oct-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||86932||Nov-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||87100||Nov-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||87068||Nov-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||87156||Dec-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||87261||Dec-17|
|0023-0240-04||REFRESH P.M.® 3.5 g||87493||Jan-18|
|0023-0240-04||REFRESH P.M.® 3.5 g||87494||Feb-18|
|0023-0240-04||REFRESH P.M.® 3.5 g||87731||Feb-18|
|0023-0240-04||REFRESH P.M.® 3.5 g (Professional Sample Pack)||85165||May-17|
|0023-0240-04||REFRESH P.M.® 3.5 g (Professional Sample Pack)||86789||Oct-17|
|0023-0316-04||FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g||86258||Sep-17|
|0023-0316-04||FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g||87189||Dec-17|
|0023-0316-04||FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g||87514||Feb-18|
|0023-0313-04||Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g||86430||Sep-17|
|0023-0313-04||Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g||87806||Feb-18|
|0023-0313-04||Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g||88147||Mar-18|
Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. The recall only applies to specific lots of the REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1%, Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%. This recall does not affect any other REFRESH or Allergan product.
Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
The company is asking consumers who currently have product from any of the affected lots of REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1% , Blephamide® (sulfacetamide sodium or prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, to stop using the product and return it to Allergan.
If there are questions or if assistance is required in response to this recall, please use the contact information below.
Contact GENCO at:
7 am to 5 pm CST
Contact Allergan at:
7am to 5pm PST
1-800-433-8871 option 2 8am - 5pm PST
Adverse Events/Products Complaints:
1-800-624-4261 Option 3 (8am - 5pm CST)
|FDA contact information for reporting adverse events/quality complaints:|
Online at www.fda.gov/medwatch/report.htm or call FDA at 1-800-FDA-1088
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this product.
Recalled Product Photos Are Also Available on FDA’s Flickr Photostream.