Promethazine HCl Oral Solution recalled over manufacturing violations
- Recall date
- April 26, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Akorn, Inc. recalls Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC,…
- Recall number
- D-0838-2023
- 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
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
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