FDA Drug recall D-0781-2016
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only by Astrazeneca Pharmaceuticals, citing defective Delivery System: Some units have actuation counters set to a number other than 60.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0781-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-05 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Astrazeneca Pharmaceuticals |
| Distribution | US |
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
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Identifiers
| code_info | Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0781-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.