FDA recall D-0912-2023

Product

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the USA

Key facts

Status

Terminated

Initiation date

2023-02-09

Report date

2023-07-19

Termination date

2023-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0912-2023