FDAFDA · Food and drugs·Recall number D-394-2014
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).
Published January 8, 2014 · Recall initiated: December 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qualitest Pharmaceuticals
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14; L082K12A, exp. 4/14; L062M12A, exp. 6/14; L063M12A, exp. 6/14; L064M12A, exp. 6/14; L054A13A, exp. 7/14; L055A13A, exp. 7/14; L057A13A, exp. 7/14; L058A13A, exp. 7/14; L075B13A, exp. 8/14; L076B13A, exp 8/14; L003C13A, exp. 8/14; L004C13A, exp. 8/14; and L005C13A, exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B, exp. 4/14; L082K12B, exp. 4/14; L059A13A, exp. 7/14; L114E13A, exp. 10/14; L026G13A, exp. 12/14; and L081J13A, exp. 3/15.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.