Class II
Terminated
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.
This recall has been terminated (originally issued March 30, 2016).
- Company
- Astrazeneca Pharmaceuticals Lp
- Recall Initiated
- February 5, 2016
- Posted
- March 30, 2016
- Recall Number
- D-0781-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 148,331 Inhalers
- Firm Location
- Wilmington, DE, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Distribution
US: Nationwide Including Puerto Rico
Lot / Code Info
Lot # 1144394, Expiry: 04/2018; Lot # 1145539, Expiry: 04/2018; Lot # 1145868, Expiry: 05/2018.
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