Active Recall
FDA Public Warning
Manufacturing Violations
Generic
Brand:Rite Aid Pharmacy
Generic for:Systane Gel
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, Sodium borate, Sodium Chloride, Stabilized oxychloro complex, Zinc chloride may contain hydrochloric acid and/or Sodium hydroxide to adjust pH.
NDC(s):11822-4540-3
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