Careone Allergy Relief Tablet, Film Coated
FDA Recall NDC 41520-229
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 Careone Allergy Relief (NDC 41520-229). A significant event, classified as Class II, was initiated on Jul 27, 2021 by American Sales Company. The reported reason for this action was: "Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during 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
July 2021 Class II Recall: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Jul 27, 2021
Jan 12, 2022
28776 containers
Recall Profile & Regulatory Data
Event ID
88384
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Perrigo Company PLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Nov 08, 2022
Product Description
CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic
Batch or Lot Expiration Information
Lot# Lot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022
Affected Packages Involved in this Recall
41520-229-95Product
41520-229-39Product
41520-229-22Product
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.
