Perrigo Company PLC recalls TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, ND
Recalled January 12, 2022 · FDA recall D-0350-2022 · Perrigo Company
Hazard
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. · FDA Class II
Units
13,656 containers
Sold at
Nationwide in the USA
Description
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Product
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic,
Manufacturer(s)
Perrigo Company PLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →