Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tudorza Pressair (aclindinium bromide inhalation powder) Recalled by AstraZeneca Pharmaceuticals LP Due to Defective Delivery System: Some units have actuation counters...

Date: February 5, 2016
Company: AstraZeneca Pharmaceuticals LP
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AstraZeneca Pharmaceuticals LP directly.

Affected Products

Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60.

Quantity: 148,331 Inhalers

Why Was This Recalled?

Defective Delivery System: Some units have actuation counters set to a number other than 60.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AstraZeneca Pharmaceuticals LP

AstraZeneca Pharmaceuticals LP has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report