FDA recall D-1868-2019

Aurolife Pharma, LLC · Class II · drug

Product

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

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-1868-2019