Drug & medication recalls Moderate risk

Levofloxacin Ophthalmic Solution 0 recalled over manufacturing violations

Recall date
October 13, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Akorn, Inc. recalls Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. N…
Recall number
D-0142-2023
FDA classification
Class II
Brand / firm
Akorn, Inc.
Sold / distributed
Nationwide in the USA

Why it was recalled

CGMP Deviations:

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

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