Cetirizine Hydrochloride Tablet, Chewable
FDA Recall NDC 47335-343
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Cetirizine Hydrochloride (NDC 47335-343). A significant event, classified as Class III, was initiated on Apr 18, 2017 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Apr 18, 2017
May 31, 2017
13,200 bottles
Recall Profile & Regulatory Data
Event ID
77103
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
May 18, 2018
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.
Batch or Lot Expiration Information
Lot# : JKR5135A, Exp 11/17
Affected Packages Involved in this Recall
47335-343-83Product
47335-343-88Product
47335-344-83Product
47335-344-88Product
Class III Terminated
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Apr 09, 2014
May 07, 2014
128,363 bottles
Recall Profile & Regulatory Data
Event ID
67971
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Caraco Pharmaceutical Laboratories, Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 07, 2014
Product Description
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Batch or Lot Expiration Information
Lot# JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
Affected Packages Involved in this Recall
47335-343-83Product
47335-343-88Product
47335-344-83Product
47335-344-88Product
Class III Terminated
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Apr 09, 2014
May 07, 2014
47,813 bottles
Recall Profile & Regulatory Data
Event ID
67971
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Caraco Pharmaceutical Laboratories, Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 07, 2014
Product Description
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Batch or Lot Expiration Information
Lot# JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
Affected Packages Involved in this Recall
47335-343-83Product
47335-343-88Product
47335-344-83Product
47335-344-88Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
