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
04/2018Lot # 1145539
- Expiry
04/2018Lot # 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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