FDAFDA · Food and drugs·Recall number D-0561-2021
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
Published June 2, 2021 · Recall initiated: March 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE
- Manufacturer
- Cardinal Health Inc.
- Distributor
- FL, GA, SC
- Lot
- 2000655C00
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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