Cardinal Health Inc. recalls Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4
Recalled June 2, 2021 · FDA recall D-0561-2021 · Cardinal Health
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage. · FDA Class II
Units
905 inhalers
Sold at
FL, GA, SC
Description
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20
Manufacturer(s)
Cardinal Health Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →