FDA recall D-1417-2012

Product

HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.

Reason for recall

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-07-06

Report date

2012-07-25

Termination date

2013-12-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1417-2012