FDA recall D-1864-2019

Aurolife Pharma, LLC · Class II · drug

Product

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21

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-1864-2019