FDA recall D-1239-2015

Qualitest Pharmaceuticals · Class III · drug

Product

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

Reason for recall

Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-06-29
Report date: 2015-07-22
Termination date: 2016-10-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1239-2015