Recalls / Class II
Class IID-0781-2016
Product
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.
- Affected lot / code info
- Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
Why it was recalled
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Recalling firm
- Firm
- AstraZeneca Pharmaceuticals LP
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1800 Concord Pike, P.O. Box 15437, Health Services Medical FOC 1, Wilmington, Delaware 19850-5437
Distribution
- Quantity
- 148,331 Inhalers
- Distribution pattern
- US: Nationwide Including Puerto Rico
Timeline
- Recall initiated
- 2016-02-05
- FDA classified
- 2016-03-22
- Posted by FDA
- 2016-03-30
- Terminated
- 2017-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0781-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.