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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