Product: Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
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