Tobramycin 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 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest,…
- Recall number
- D-0157-2023
- 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
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10
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