FDA recall D-0444-2025

Product

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, .

Reason for recall

Defective delivery system

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2025-05-14

Report date

2025-05-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2025