FDA-Drug2016-03-30Class II
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.
AstraZeneca Pharmaceuticals LP
Hazard
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Sold states
US: Nationwide Including Puerto Rico
Affected count
148,331 Inhalers
Manufactured in
1800 Concord Pike, P.O. Box 15437, Health Services Medical FOC 1, Wilmington, DE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0781-2016Don't want to check this manually?
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