TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, ND
Summary
The FDA issued a Class II for TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihist by Perrigo Company PLC. Reason: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing..
Details
Source
Drug Recall
External ID
D-0350-2022
Action Date
2022-01-12
Status
Terminated
Category
drug
Product Description
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,
Lot/Code Info: Lot # a) 0KE2429, Exp 02/28/2022; b) 0HE2530, Exp 12/31/2021; c)0FR0460, Exp 02/28/2022; d)0GR0531, Exp 03/31/2022 ; 0KR0465, Exp 04/302022
Quantity Affected: 13,656 containers
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-27
Company
Allegan, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 77 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Perrigo Company PLC has 81 FDA actions in our database, including 81 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Perrigo Company PLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Perrigo Company PLC have FDA actions?
Perrigo Company PLC has 81 FDA actions in our database, including 81 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0350-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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