Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
Recall Number: D-0857-2017
Firm: Sun Pharmaceutical Industries, Inc.
Classification: Class III
Status: Terminated
Report Date: 20170531
Initiation Date: 20170418
Termination Date: 20180518
Reason for Recall
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Product Description
Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.