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.

Recall Number: D-0328-2022

Firm: Perrigo Company PLC

Classification: Class II

Status: Terminated

Report Date: 20220112

Initiation Date: 20210727

Termination Date: 20221108

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

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.