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FDA Medwatch Alert: Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter

Posted 25 Aug 2015 by Drugs.com

ISSUE: Allergan 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 PM 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. For specific lot numbers, see the Firm Press Release. BACKGROUND: 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. Specific ... Read more

Related support groups: Eye Conditions, FML, Blephamide, FML SOP, Refresh Lacri-Lube, FML Liquifilm, Refresh PM, Blephamide SOP

Surge in Pollen May Spur Many Cases of Dry Eye

Posted 29 Apr 2015 by Drugs.com

WEDNESDAY, April 29, 2015 – High pollen levels in the spring are linked to dry eye, a new study suggests. "Finding this correlation between dry eye and different seasons is one step toward helping physicians and patients treat the symptoms of dry eye even more effectively based on the time of year," said lead researcher Dr. Anat Galor, an associate professor of clinical ophthalmology at the University of Miami. Dry eye causes burning, irritation and blurred vision. It costs the U.S. health system nearly $4 billion a year, Galor's team said in background information with the study. The researchers analyzed 3.4 million visits to Veterans Affairs eye clinics nationwide between 2006 and 2011. During that time, nearly 607,000 cases of dry eye were diagnosed. April had the highest rate of patients diagnosed with dry eye, nearly 21 percent. April is also when pollen levels usually peak each ... Read more

Related support groups: Allergic Reactions, Allergies, Benadryl, Hydroxyzine, Zyrtec, Promethazine, Claritin, Allegra, Loratadine, Diphenhydramine, Allergic Rhinitis, Eye Dryness/Redness, Phenergan, Hay Fever, Cetirizine, Vistaril, Cyproheptadine, Atarax, Fexofenadine, Periactin

FDA Medwatch Alert: Altaire Pharmaceuticals Carboxymethylcellulose Sodium 0.5 Percent Ophthalmic Solution Sold Under Wal-Mart, CVS, and Target Brands: Recall - Preservative May Not Be Effective Through Expiry

Posted 9 Sep 2013 by Drugs.com

ISSUE:  Altaire Pharmaceuticals, Inc., announced that it is voluntarily recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. Due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall. A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection. BACKGROUND: Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. The product is labeled as follows (refer the Firm Press Release for a detailed product list containing affected lot numbers): equate Restore Tears Lubricant Eye ... Read more

Related support groups: Systane, Soothe, Refresh, GenTeal, Artificial Tears, FreshKote, Lacrisert, Lacri-Lube SOP, Murine, Lubricant Eye Drops, Ocular Lubricant, optive, Celluvisc, Tears Naturale II, Tears Plus, Systane Ultra, Refresh Liquigel, Tears Naturale PM, Hypotears P/F, Tears Again

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