FDA recall D-0431-2021

Cardinal Health Inc. · Class II · drug

Product

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328

Reason for recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution

FL, GA, SC

Key facts

Status: Terminated
Initiation date: 2021-03-15
Report date: 2021-06-02
Termination date: 2024-06-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0431-2021