Budesonide and Formoterol Fumarate Dihydrate Inhalation recall: CGMP Deviations
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120…
Why was Budesonide and Formoterol Fumarate Dihydrate Inhalation recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2000655C00
- Product
- Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120…
- Recalling firm
- Cardinal Health Inc.
- Quantity
- 905 inhalers
- Distribution
- FL, GA, SC
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)