Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesso
Summary
The FDA issued a Class II for Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 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-0337-2022
Action Date
2022-01-12
Status
Terminated
Category
drug
Product Description
Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3
Lot/Code Info: Lot 0JE2491, Exp 1/31/2022
Quantity Affected: 12,384 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-0337-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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