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.
Reason for recall: Defective Delivery System: Some units have actuation counters set to a number other than 60.
Recall initiated: 20160205
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated