# FDA recall D-0781-2016

> **AstraZeneca Pharmaceuticals LP** · Class II · drug recall initiated 2016-02-05.

## Product

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.

## Distribution

US: Nationwide Including Puerto Rico

## Key facts

- **Recall number:** D-0781-2016
- **Recalling firm:** AstraZeneca Pharmaceuticals LP
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-02-05
- **Report date:** 2016-03-30
- **Termination date:** 2017-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wilmington, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0781-2016

## Citation

> AI Analytics. FDA recall D-0781-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0781-2016. Source: US FDA. Licensed CC0.

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