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Attention Members and Providers: Tudorza Pressair Inhaler Recall

Date: 04/27/16

Attention Members and Providers: MHS wants you to know about a recent drug recall.

The U.S. Food and Drug Administration (FDA) issued an Enforcement Report regarding AstraZeneca Pharmaceuticals LP. It is for Tudorza Pressair Inhaler (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per inhaler (prescription only). The FDA issued the recall due to a defective delivery system. Some units have actuation counters set to a number other than 60.

The recall affects lot numbers 1144394, 1145539, and 1145868 of Tudorza Pressair Inhaler (aclindinium bromide inhalation powder), 400 mcg per actuation currently on the market.

Please call your pharmacy to find out if your drug could be part of the recall. The pharmacy may replace the drug. Please do not stop taking your drug. It is important that you do not make any changes in therapy without first consulting your doctor.



Last Updated: 05/05/2017