US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 5, 2016 (11 years ago)

Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
AstraZeneca Pharmaceuticals LP
Origin
DE, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0781-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.