Active Recall
FDA Public Warning
Manufacturing Violations
Generic
Brand:Up & Up
Generic for:Systane Ultra
Country of Manufacture:India
Package Type:Multi-dose bottle
Contains preservative(s):Yes
Preservative:stabilized oxychloro complex
Active ingredient(s):Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%
Inactive ingredient(s):boric acid, calcium chloride, disodium edetate, hypromellose, magnesium chloride, potassium chloride, purified water, stabilized oxychloro complex, sodium chloride, zinc chloride, sodium borate, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
NDC(s):11673-522-15
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