Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth
Summary
The FDA issued a Class I for Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactu by Alcon Research LLC. Reason: Non-Sterility.
Details
Source
Drug Recall
External ID
D-0200-2025
Action Date
2025-01-22
Status
Ongoing
Category
drug
Product Description
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Lot/Code Info: Lot 10101; Exp.09/30/2025
Quantity Affected: 55,960 25-count boxes
Reason for Recall
Non-Sterility
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-18
Company
Fort Worth, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 99 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Alcon Research LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alcon Research LLC have FDA actions?
Alcon Research LLC has 66 FDA actions in our database, including 66 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0200-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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