FDA recall D-1870-2019

Aurolife Pharma, LLC · Class II · drug

Product

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, 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-1870-2019