FDA-Drug2022-01-12Class II

H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9

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
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0339-2022

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