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 for recall: Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recall initiated: 20210727
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated