Class II Recall

Perrigo Company PLC

Product
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
Reason
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Classification
Class II
Status
Terminated
Lot
Lot # a)0HE2530 Exp 12/31/2021, 0KE2980 EXP 02/28/2022 b)0FR0461 Exp 2/28/2022
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.
Perrigo Company PLC — Class II Recall | MedicineWatch US