Olopatadine HCl Ophthalmic Solution recalled over manufacturing violations
- Recall date
- October 13, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, I…
- Recall number
- D-0149-2023
- 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
Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
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