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.

Recall Number: D-1417-2012

Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Classification: Class III

Status: Terminated

Report Date: 20120725

Initiation Date: 20120706

Termination Date: 20131209

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

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.