Active Recall
FDA Public Warning
Manufacturing Violations
Generic
Brand:Leader
Generic for:Refresh Tears Lubricant Eye Drops
Country of Manufacture:India
Package Type:Multi-dose bottle
Contains preservative(s):Yes
Preservative:Stabilized oxychloro complex
Active ingredient(s):Carboxymethylcellulose Sodium 0.5%
Inactive ingredient(s):Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
NDC(s):70000-0090-1
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