Tudorza Pressair — Class II drug recall D-0781-2016
Terminated recall by AstraZeneca Pharmaceuticals LP, reported 2016-03-30, distributed nationwide. Defective Delivery System: Some units have actuation counters set to a number other than 60.
| Recall number | D-0781-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AstraZeneca Pharmaceuticals LP, Wilmington, DE, United States |
| Recall initiated | 2016-02-05 |
| Classified | 2016-03-22 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 148,331 inhalers |
| NDC | 00310-0800-60 |
| Lot numbers | 1144394, 1145539, 1145868 |
| Expiration dates | 2018-04, 2018-05 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0781-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.