Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation cani
Summary
The FDA issued a Class II for Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhala by AsttraZeneca Pharmaceuticals LP. Reason: Defective delivery system.
Details
Source
Drug Recall
External ID
D-0444-2025
Action Date
2025-05-28
Status
Ongoing
Category
drug
Product Description
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
Lot/Code Info: Lot#: a) 6270044C00, 6270040D00, 6270034E00, Exp Date 10/2026; 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00 Exp 11/30/2026; 6270064C00, 6270071D00, 6270075D00, 6270075F00 Exp Date 12/31/2026; 6270107C00, Exp Date 9/30/2027; b) Lot 6270019E00, Exp Date 7/31/2025; 6270021D00, Exp 8/31/2025; 6270095C00, Exp 2/28/2026
Quantity Affected: a) 807,837 canisters; b) 235,698 canisters
Reason for Recall
Defective delivery system
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-14
Company
Wilmington, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AsttraZeneca Pharmaceuticals LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AsttraZeneca Pharmaceuticals LP have FDA actions?
This is the only FDA action we have on record for AsttraZeneca Pharmaceuticals LP in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0444-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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