HydrOXYzine HYDROCHLORIDE SYRUP recalled over manufacturing violations
- Recall date
- October 11, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lannett Company, Inc. recalls HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by…
- Recall number
- D-0083-2019
- FDA classification
- Class II
- Brand / firm
- Lannett Company, Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
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