D-0781-2016 Class II Terminated
FDA drug recall D-0781-2016 was initiated by AstraZeneca Pharmaceuticals LP on Feb 5, 2016 and is designated Class II. Reason for recall: Defective Delivery System: Some units have actuation counters set to a number other than 60. The recall status is terminated (terminated Jun 20, 2017). Affected quantity: 148,331 Inhalers.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 30, 2016
- Initiation Date
- Feb 5, 2016
- Termination Date
- Jun 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148,331 Inhalers
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.
Distribution Pattern
US: Nationwide Including Puerto Rico
Code Information
Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0781-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026