Children's Cetirizine Hydrochloride Chewable Tablets…

Date

May 31, 2017

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries, Inc.

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

Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

Distribution pattern

Nationwide in the USA and Puerto Rico

Quantity

13,200 bottles

Codes and lots

Lot #: JKR5135A, Exp 11/17

Recall started

April 18, 2017

Recall number

D-0857-2017

What should I do? A baby or kids' product was recalled: what to do

Source: FDA · Drug enforcement report, recall number D-0857-2017. The agency record governs; check it and the company before acting.