D-0781-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 30, 2016
- Initiation Date
- February 5, 2016
- Termination Date
- June 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.