Drug Enforcement D-0200-2025

Non-Sterility

Status

Ongoing

Classification

Class I

Report Date

January 22, 2025

Termination Date

—

Product Information

Product description
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Product quantity
55,960 25-count boxes
Reason for recall
Non-Sterility
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Alcon Research LLC
Address
6201 South Fwy

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0200-2025
Event ID
96003
Recall initiation date
December 18, 2024
Center classification date
January 13, 2025
Code info
Lot 10101; Exp.09/30/2025
More code info
—