FDA-Drug2022-01-12Class II
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
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
26,304 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0349-2022Don't want to check this manually?
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