CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, 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) 0ME2516, Exp 4/30/2022 b)0ME2515, Exp 4/30/2022; 0KE2982, Exp 1/31/2022
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.