PhotoAllergan is recalling the following eye treatment medications:

 

  • REFRESH Lacri-Lube 3.5-g and 7-g for dry eye
  • REFRESH P.M. 3.5-g for dry eye
  • FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5-g) and
  • Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5-g.

The recall is based on a small number of customer complaints which reported a small black particle at the time of use. This 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).

 

The following products are being recalled:

NDCDescriptionLot NumberExpiration Date
0023-0312-04REFRESH® Lacri-Lube® 3.5 g84746 Apr-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g84987May-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85087May-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85359Jun-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85721Jul-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86045Aug-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86406Sep-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86594Oct-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g87021Nov-17
0023-0312-07REFRESH® Lacri-Lube® 7g86470Sep-17
0023-0312-07REFRESH® Lacri-Lube® 7g86829Oct-17
0023-0312-07REFRESH® Lacri-Lube® 7g87105Nov-17
0023-0240-04REFRESH P.M.® 3.5 g85165May-17
0023-0240-04REFRESH P.M.® 3.5 g85228May-17
0023-0240-04REFRESH P.M.® 3.5 g85244Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85351Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85374Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85397Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85561Jul-17
0023-0240-04REFRESH P.M.® 3.5 g85676Jul-17
0023-0240-04REFRESH P.M.® 3.5 g85694Jul-17
0023-0240-04REFRESH P.M.® 3.5 g85834Aug-17
0023-0240-04REFRESH P.M.® 3.5 g85977Aug-17
0023-0240-04REFRESH P.M.® 3.5 g85985Aug-17
0023-0240-04REFRESH P.M.® 3.5 g86073Aug-17
0023-0240-04REFRESH P.M.® 3.5 g85599Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86290Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86325Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86411Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86427Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86506Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86515Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86517Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86746Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86792Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86789Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86809Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86822Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86822AOct-17
0023-0240-04REFRESH P.M.® 3.5 g86932Nov-17
0023-0240-04REFRESH P.M.® 3.5 g87100Nov-17
0023-0240-04REFRESH P.M.® 3.5 g87068Nov-17
0023-0240-04REFRESH P.M.® 3.5 g87156Dec-17
0023-0240-04REFRESH P.M.® 3.5 g87261Dec-17
0023-0240-04REFRESH P.M.® 3.5 g87493Jan-18
0023-0240-04REFRESH P.M.® 3.5 g87494Feb-18
0023-0240-04REFRESH P.M.® 3.5 g87731Feb-18
0023-0240-04REFRESH P.M.® 3.5 g (Professional Sample Pack)85165May-17
0023-0240-04REFRESH P.M.® 3.5 g (Professional Sample Pack)86789Oct-17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g
 
86258Sep-17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g
 
87189Dec-17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g
 
87514Feb-18
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g86430Sep-17
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g87806Feb-18
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g88147Mar-1
88147Mar-18

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.

 

Consumers who currently have the recalled products should stop using the product and return them to Allergan.

CONTACT INFORMATION  
Product Returns
Contact GENCO at:
877-674-2087
7 am to 5 pm CST
Credit/Reimbursements
Contact Allergan at:
1-800-811-4148
7am to 5pm PST
Allergan
Medical Inquiries
:

1-800-433-8871 option 2 8am - 5pm PST

Adverse Events/Products Complaints:

1-800-624-4261 Option 3 (8am - 5pm CST)

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