FDA-Drug2022-01-12Class II

Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1

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
6,960 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0338-2022

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