Drug & medication recalls Moderate risk

Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Fores…

Recall date
October 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0414-2019
FDA classification
Class II
Brand / firm
Akorn, Inc.
Sold / distributed
Nationwide USA and Puerto Rico

Why it was recalled

Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.

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

What was recalled

Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

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