Product: Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg,  30 count bottle, OTC,  Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL,  NDC 47335-344-83
Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Recall initiated: 20140409
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated