Topcare Allergy Relief Tablet, Film Coated
FDA Recall NDC 36800-691
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 Topcare Allergy Relief (NDC 36800-691). A significant event, classified as Class II, was initiated on Feb 09, 2023 by Topco Associates Llc. 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
44,280 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) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.
Batch or Lot Expiration Information
Lot# : a) 2FV1948, 2ER0285, 2ER0411, Exp. Date 01/24 b)2CR0653, Exp. Date 12/23 c)2GR0331, Exp. Date 04/24
Affected Packages Involved in this Recall
36800-691-13Product
36800-691-39Product
36800-691-22Product
36800-691-49Product
36800-691-95Product
36800-691-75Product
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.
