Product: 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.
Reason for recall: Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Recall initiated: 20170418
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated