Product: Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Reason for recall: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Recall initiated: 20260421
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated