CLASS II Drug recall · Reported 30 Mar 2016 · FDA Enforcement Report
Tudorza Pressair (aclindinium bromide inhalation powder) recalled
AstraZeneca Pharmaceuticals is recalling Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60, distributed nationwide in the US. The recall was initiated on 5 Feb 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0781-2016
- FDA event ID
- 73538
- Recalling firm
- AstraZeneca Pharmaceuticals, Wilmington, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Feb 2016
- FDA classified
- 22 Mar 2016
- Reported
- 30 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 5 Feb 2016 | Recall initiated by company | |
| 22 Mar 2016 | Classified by FDA | +46 days |
| 30 Mar 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Product as listed by the FDA
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.
Where it was distributed
US: Nationwide Including Puerto Rico
Questions about this recall
Why was it recalled?
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Which lots are affected?
Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
Where was it sold?
US: Nationwide Including Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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