Drug recall D-0561-2021
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
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots and codes
2000655C00
Recall details
- Recalling firm
- Cardinal Health Inc., Dublin, OH
- Quantity
- 905 inhalers
- Distribution
- FL, GA, SC
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 15, 2021
- Terminated
- June 17, 2024
Related products
- Budesonide and Formoterol Fumarate Dihydrate – drug information
- NDC 0310-7372 Budesonide and Formoterol Fumarate Dihydrate · Budesonide 80 ug/1; Formoterol Fumarate 4.5 ug/1 · AstraZeneca Pharmaceuticals LP
- NDC 0310-7370 Budesonide and Formoterol Fumarate Dihydrate · Budesonide 160 ug/1; Formoterol Fumarate 4.5 ug/1 · AstraZeneca Pharmaceuticals LP