Reported Mar 30, 2016 · Terminated

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

AstraZeneca Pharmaceuticals LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AstraZeneca Pharmaceuticals LP · 1800 Concord Pike, P.O. Box 15437 · Wilmington, DE · 19850-5437

Is this the product you have?

  • Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only
  • Manufactured forAstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
  • Manufactured byForest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain
  • NDC0310-0800-60
Lot codes and dates
  • Lot # 1144394
  • Expiry
    • 04/2018
    • Lot # 1145539
  • Expiry
    • 04/2018
    • Lot # 1145868
  • Expiry05/2018
Amount recalled
148,331 Inhalers

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 20, 2017 · Data as of Sep 19, 5:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.