FDA recall D-1865-2019

Product

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.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-08-23

Report date

2019-09-25

Termination date

2022-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1865-2019