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.
Recall Number: D-0083-2019
Firm: Lannett Company, Inc.
Classification: Class II
Status: Terminated
Report Date: 20181031
Initiation Date: 20181011
Termination Date: 20190222
Reason for Recall
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Product Description
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.