FDA-Drug2014-01-08Class III
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).
Qualitest Pharmaceuticals
Hazard
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Sold states
Nationwide and Puerto Rico
Affected count
438,055 bottles
Manufactured in
120 Vintage Dr NE, Huntsville, AL, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-394-2014Don't want to check this manually?
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