Drug recall D-0781-2016

Class II Terminated reported Mar 30, 2016

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.

Lots and codes

Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.

Recall details

Recalling firm
AstraZeneca Pharmaceuticals LP, Wilmington, DE
Quantity
148,331 Inhalers
Distribution
US: Nationwide Including Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
February 5, 2016
Terminated
June 20, 2017