Drug 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.
D-0781-2016
Product summary
- Event
- Event 73538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148,331 Inhalers
- Official record key
drug-enforcement:D-0781-2016
Official wording
Reason: Defective Delivery System: Some units have actuation counters set to a number other than 60.
Code information: Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
Distribution pattern: US: Nationwide Including Puerto Rico
Derived failure modes
-
Unknown
Defective Delivery System: Some units have actuation counters set to a number other than 60.