FDA recall D-1871-2019

Product

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.

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-1871-2019