Sun Pharmaceutical Industries, Inc. recalls Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Lt
Recalled May 31, 2017 · FDA recall D-0857-2017 · Sun Pharmaceutical Industries
Hazard
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. · FDA Class III
Units
13,200 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
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.
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →