April 2017 FDA Recall Cetirizine Hydrochloride by Sun Pharmaceutical Industries, Inc.
D-0857-2017 - Failed Tablet/Capsule Specifications

This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on April 18, 2017 for the product Cetirizine Hydrochloride. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0857-2017

Reason for Recall
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Initiated
04-18-2017
Reported
05-31-2017
Quantity
13,200 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77103
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-18-2018
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : JKR5135A, Exp 11/17

Affected Packages Involved in this Recall

47335-343-83 Cetirizine Hydrochloride
47335-343-88 Cetirizine Hydrochloride
47335-344-83 Cetirizine Hydrochloride
47335-344-88 Cetirizine Hydrochloride