Active Recall
FDA Public Warning
Manufacturing Violations
Generic
Brand:Leader
Generic for:Systane Complete Lubricant Eye Drops
Country of Manufacture:India
Package Type:Multi-dose bottle
Contains preservative(s):Yes
Preservative:Benzalkonium chloride
Active ingredient(s):Propylene Glycol 0.6%
Inactive ingredient(s):benzalkonium chloride solution, boric acid, calcium chloride, castor oil, disodium edetate, magnesium chloride, polyoxyl 40 hydrogenated castor oil, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, May contain sodium hydroxide, hydrochloric acid to adjust the pH
NDC(s):70000-0587-1
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
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
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