FDA recall D-0083-2019

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-10-11

Report date

2018-10-31

Termination date

2019-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Philadelphia, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0083-2019