FDAFDA · Food and drugs·Recall number D-0781-2016
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.
Published March 30, 2016 · Recall initiated: February 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System: Some units have actuation counters set to a number other than 60.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Distributor
- US: Nationwide Including Puerto Rico
- Lot
- Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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