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).
Reported: January 8, 2014 Initiated: December 16, 2013 #D-394-2014
Product Description
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.
Details
- Recalling Firm
- Qualitest Pharmaceuticals
- Units Affected
- 438,055 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Huntsville, AL
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Qualitest Pharmaceuticals. Units affected: 438,055 bottles.
Why was this product recalled? ▼
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2014. Severity: Low. Recall number: D-394-2014.
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