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I know that this has already been posted about, but I just want to maximize exposure by putting it in the open forum, since the products affected are in common use by many DES patients:
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
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.
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.
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