Active Recall
FDA Public Warning
Manufacturing Violations
Possible Frankenstein Eye Drop
Generic
Brand:Leader
Generic for:Systane Lubricant Gel Drops
Country of Manufacture:India
Package Type:Multi-dose bottle
Contains preservative(s):Cannot determine
Active ingredient(s):Polyethylene Glycol 400 0.4%, Propylene Glyco 0.3% per FDA public warning. No FDA-registered ingredient list.
Inactive ingredient(s):See DailyMed link. Ingredients in FDA database do not match ingredients on product label uploaded to FDA database.
NDC(s):70000-0088-1
FDA Action:3/28/24 Warning Letter to Kilitch Healthcare India Limited
11/15/23 Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons
11/2/23 Cardinal Health Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma LLC Due to Potential Risk of Eye Infections
10/27/23 FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
11/15/23 Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons
11/2/23 Cardinal Health Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma LLC Due to Potential Risk of Eye Infections
10/27/23 FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection
Last updated:3-28-24