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

Recall Number: D-0491-2026

Firm: Alcon Research LLC

Classification: Class II

Status: Ongoing

Report Date: 20260506

Initiation Date: 20260421

Termination Date:

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

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