Drug & medication recalls High risk

Systane Lubricant Eye Drops recalled over sterility concerns

Recall date
December 18, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Alcon Research LLC recalls Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth…
Recall number
D-0200-2025
FDA classification
Class I
Brand / firm
Alcon Research LLC
Sold / distributed
US Nationwide.

Why it was recalled

Non-Sterility

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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

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