FDA-Drug2022-01-12Class II
CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic
Perrigo Company PLC
Hazard
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Sold states
Nationwide in the USA
Affected count
28776 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2022Don't want to check this manually?
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