FDAClass IIMarch 30, 2016

Tudorza Pressair recall

Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca…

Why was Tudorza Pressair recalled?

Defective Delivery System: Some units have actuation counters set to a number other than 60.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca…
Recalling firm
AstraZeneca Pharmaceuticals LP
Quantity
148,331 Inhalers
Distribution
US: Nationwide Including Puerto Rico
Recall date
March 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls