Litigation Follows OTC Eye Drops Recall Due To Bacteria Strain Not Previously Seen In US
Complaints Against EzriCare, Delsam, Aru Pharma Follow US Warning To Manufacturer In India
Executive Summary
Following a recall earlier in February of EzriCare’s and Delsam’s OTC artificial tears due to potential bacterial contamination, plaintiffs’ bar steps in with first of what may be multiple lawsuits. CDC says drug-resistant strain of Pseudomonas aeruginosa bacteria not previously seen in US.
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FDA says FivFivGo, Rebright and South Moon are copycats in packaging easily mistaken for Lumify OTC eye drops. Testing found South Moon contaminated with bacteria linked to an antibiotic-resistant infection; agency warns using any of the three poses risk of eye infection.
‘Pervasive Contamination’ Found At Indian Eye Drop Firm Linked To Antibiotic-Resistant Infections
FDA also responds to sting OTC eye drop sector felt with warnings to Amazon after investigators purchased drops labeled with violative claims and a natural health care products firm with Amazon storefront offering drops with ingredient commonly used in joint health supplements and claims to “soften the membranes of the eye.”
Eye Drop Production Sterility Problems Bring Reason For US FDA Guidance Into Sharper Focus
Since FDA provided draft guidance on quality considerations for ophthalmic drugs, steady stream has continued of OTC brand recalls due to manufacturers’ failure to ensure sterility in production processes and purity of ingredients and other components.