Childrens Allergy Solution
FDA Recall NDC 56062-106
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Childrens Allergy (NDC 56062-106). A significant event, classified as Class II, was initiated on Oct 19, 2018 by Publix Super Markets Inc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing."
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
October 2018 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Oct 19, 2018
Nov 21, 2018
8328 bottles
Recall Profile & Regulatory Data
Event ID
81483
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 03, 2020
Product Description
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
Batch or Lot Expiration Information
Lot# 313345, Exp 12/18
Affected Packages Involved in this Recall
56062-106-08Product
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.
