Lannett Company, Inc. recalls HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by
Recalled October 31, 2018 · FDA recall D-0083-2019 · Lannett
Hazard
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. · FDA Class II
Units
8,324 bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Product
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.
Manufacturer(s)
Lannett Company, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →