FDA recall D-0908-2023

Product

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010.

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-0908-2023