AstraZeneca Pharmaceuticals LP recalls Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only.
Recalled March 30, 2016 · FDA recall D-0781-2016 · AstraZeneca Pharmaceuticals
Hazard
Defective Delivery System: Some units have actuation counters set to a number other than 60. · FDA Class II
Units
148,331 Inhalers
Sold at
US: Nationwide Including Puerto Rico
Description
Defective Delivery System: Some units have actuation counters set to a number other than 60.
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.
Manufacturer(s)
AstraZeneca Pharmaceuticals LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →