FDA recall D-1867-2019

Aurolife Pharma, LLC · Class II · drug

Product

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.

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-1867-2019