Home / Recalls / Lannett Company, Inc. / D-0083-2019

D-0083-2019 Class II Terminated

Recalled by Lannett Company, Inc. — Philadelphia, PA

Recall Details

Product Type
Drugs
Report Date
October 31, 2018
Initiation Date
October 11, 2018
Termination Date
February 22, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,324 bottles

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.

Reason for Recall

CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1097, Exp 10/18

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