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
Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Classification
Class II
Status
Terminated
Lot
Lot a) 0FR0459, Exp 2/28/2022; 0LR0362, Exp 6/30/2022; 1BR0462, Exp 10/31/2022 b) 0LR0363, Exp 6/30/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.