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.
Recall initiated: 20120706
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated