← FDA ENFORCEMENT
D-0200-2025Class I

Alcon Research LLC

Recalling firm
Alcon Research LLC
Product type
Drug
Status
Ongoing
Report date
2025-01-22
Distribution
US Nationwide.
Firm state
TX
Product quantity
55,960 25-count boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Non-Sterility

Product description

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Code / lot info

Lot 10101; Exp.09/30/2025

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.