Qualitest Pharmaceuticals recalls Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only
Recalled January 8, 2014 · FDA recall D-394-2014 · Qualitest Pharmaceuticals
Hazard
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. · FDA Class III
Units
438,055 bottles
Sold at
Nationwide and Puerto Rico
Description
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Product
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Manufacturer(s)
Qualitest Pharmaceuticals
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →