Allergy Relief Tablet, Film Coated
FDA Recall NDC 79481-0847
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 Allergy Relief (NDC 79481-0847). A significant event, classified as Class II, was initiated on Feb 09, 2023 by Meijer, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
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
February 2023 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Feb 09, 2023
Jul 19, 2023
59,688 cartons
Recall Profile & Regulatory Data
Event ID
91672
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
L. Perrigo Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Termination Date
Sep 11, 2023
Product Description
allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
Batch or Lot Expiration Information
Lot# : a) 2JE1882, Exp. date 01/24 b) 2FV1918, 2ER0411, Exp. date 01/24; 2GV1902, Exp. date 04/24; 2CR0652, 2DR0465, Exp. date 12/23; 2GR0329, Exp. date 04/24 c)2CR0653, 2DR0466, Exp. date 12/23; 2ER0287, 2ER0412, Exp. date 01/24
Affected Packages Involved in this Recall
79481-0847-1Product
79481-0847-0Product
79481-0847-2Product
79481-0847-4Product
79481-0847-3Product
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.
