FDA-Drug2022-01-12Class II
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of 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
13,920 containers
Manufactured in
515 Eastern Ave, N/A, Allegan, MI, United States
Products
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2022Don't want to check this manually?
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