Gonak Hypromellose Ophthalmic Solution 25mg/mL recalled over manufacturing violations
- Recall date
- April 26, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Akorn, Inc. recalls Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6…
- Recall number
- D-0805-2023
- FDA classification
- Class II
- Brand / firm
- Akorn, Inc.
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
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