FDA-Drug2018-10-31Class II
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.
Lannett Company, Inc.
Hazard
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Sold states
Nationwide in the USA
Affected count
8,324 bottles
Manufactured in
9000 State Rd, N/A, Philadelphia, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2019Don't want to check this manually?
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