Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon La...
FDA Recall #D-0200-2025 — Class I — December 18, 2024
Product Description
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Reason for Recall
Non-Sterility
Recalling Firm
Alcon Research LLC — Fort Worth, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
55,960 25-count boxes
Distribution
US Nationwide.
Code Information
Lot 10101; Exp.09/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated