Class II Recall

Perrigo Company PLC

Product
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Classification
Class II
Status
Terminated
Lot
Lot 0JE2491, 0LE2178, Exp 01/31/2022; 0ME2516, Exp 4/30/2022
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.