Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACE
Recalled July 25, 2012 · FDA recall D-1417-2012 · Vintage Pharmaceuticals LLC
Hazard
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point. · FDA Class III
Units
73,746 bottles
Sold at
Nationwide
Description
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
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.
Manufacturer(s)
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →