Recall: D-0083-2019

Class II - Potentially Harmful

Class IIClassification

2018-10-11Initiated

TerminatedStatus

Lannett Company, Inc.Firm

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.

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.