Active Recall
FDA Public Warning
Manufacturing Violations
Generic
Brand:Leader
Generic for:Clear Eyes Triple Action
Country of Manufacture:India
Package Type:Multi-dose bottle
Contains preservative(s):Yes
Preservative:Benzalkonium chloride
Active ingredient(s):Polyvinyl Alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%
Inactive ingredient(s):Benzalkonium Chloride, Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.
NDC(s):70000-0087-1
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