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).
Reason for recall: Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Recall initiated: 20131216
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated