FDA recall D-0174-2021

Product

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

Reason for recall

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-12-09

Report date

2020-12-30

Termination date

2022-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morton Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0174-2021