FDA-Drug2019-09-25Class II
Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
Aurolife Pharma, LLC
Hazard
Failed Impurities/Degradation Specifications
Sold states
Nationwide in the USA
Affected count
a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons
Manufactured in
2400 US Highway 130, N/A, Dayton, NJ, United States
Products
Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1865-2019Don't want to check this manually?
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