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.
Reported: March 30, 2016 Initiated: February 5, 2016 #D-0781-2016
Product Description
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.
Details
- Recalling Firm
- AstraZeneca Pharmaceuticals LP
- Units Affected
- 148,331 Inhalers
- Distribution
- US: Nationwide Including Puerto Rico
- Location
- Wilmington, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by AstraZeneca Pharmaceuticals LP. Units affected: 148,331 Inhalers.
Why was this product recalled? ▼
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 30, 2016. Severity: Moderate. Recall number: D-0781-2016.
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