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
Recall Number: D-1297-2014
Firm: Caraco Pharmaceutical Laboratories, Ltd.
Classification: Class III
Status: Terminated
Report Date: 20140507
Initiation Date: 20140409
Termination Date: 20141007
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Product Description
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