December 2024 FDA Recall Drug by Alcon Research Llc
D-0200-2025 - Non-Sterility

This Class I drug recall was voluntarily initiated by Alcon Research Llc on December 18, 2024 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0200-2025

Reason for Recall
Non-Sterility
Initiated
12-18-2024
Reported
01-22-2025
Quantity
55,960 25-count boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96003
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Alcon Research LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Batch or Lot Expiration Information

Lot# Lot 10101; Exp.09/30/2025