Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported March 30, 2016
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.
Defective Delivery System: Some units have actuation counters set to a number other than 60.
AstraZeneca Pharmaceuticals LP recalled Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Meter… - a moderate-severity action.
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Meter… was recalled by AstraZeneca Pharmaceuticals LP in March 30, 2016. Reason: Defective Delivery System: Some units have actuation counters set to a number other than 60.. Check the official notice for the remedy. Verify recall #D-0781-2016 with the FDA Drug before acting.
The recall
AstraZeneca Pharmaceuticals LP issued this moderate-severity FDA Drug recall-Defective Delivery System: Some units have actuation counters set to a number other than 60..
- Moderate
- severity level
- Class II
- classification
- March 30, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0781-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0781-2016) was formally reported on March 30, 2016, with the manufacturer initiating the action on February 5, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. AstraZeneca Pharmaceuticals LP is listed as the recalling firm, operating out of Wilmington, DE. Federal records list the affected scope as 148,331 Inhalers.
The documented reason for this recall is: Defective Delivery System: Some units have actuation counters set to a number other than 60. Distribution data in the federal record shows the product reached: US: Nationwide Including Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
148,331 Inhalers
Related Recalls
6
5 from same agency
Product description
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.
Reason for recall
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0781-2016 |
| Date reported | March 30, 2016 |
| Date initiated | February 5, 2016 |
| Recalling firm | AstraZeneca Pharmaceuticals LP |
| Firm location | Wilmington, DE |
| Affected scope | 148,331 Inhalers |
| Distribution | US: Nationwide Including Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0781-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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.. Recalled by AstraZeneca Pharmaceuticals LP. Units affected: 148,331 Inhalers.
Why was this product recalled? ▼
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 30, 2016. Severity: Moderate. Recall number: D-0781-2016.
Where was the recalled product distributed? ▼
Distribution: US: Nationwide Including Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0781-2016) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 30, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.