FDA-Drug2021-06-02Class II
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
Cardinal Health Inc.
Hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sold states
FL, GA, SC
Affected count
905 inhalers
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0561-2021Don't want to check this manually?
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