Skip to content
Recall Observatory FDA recall evidence

Drug product

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

D-0200-2025

December 18, 2024

Class I

Product summary

Firm
Alcon Research LLC
Event
Event 96003
Status
Ongoing
Classification
Class I
Quantity
55,960 25-count boxes
Official record key
drug-enforcement:D-0200-2025

Official wording

Reason: Non-Sterility

Code information: Lot 10101; Exp.09/30/2025

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility