FDA recall D-603-2013

Product

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

Reason for recall

Subpotent; 24 month stability test station

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-04-30

Report date

2013-06-26

Termination date

2016-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-603-2013