AstraZeneca announced a voluntary recall of certain lots of Tudorza Pressair (aclidinium bromide) inhalation powder where the counter ring for some devices is not initially set to “60” in the viewing window.
The device may show a blank window or a number below “60.” A blank window displayed upon opening may indicate the possibility for the device to become empty before the counter gets to “0” and locks out, which would result in no dose being delivered.
The affected products have Lot# 1144394 (exp. 4/2018), Lot# 1145539 (exp 4/2018), and Lot#1145868 (exp 5/2018). The recalled products were distributed between July 2015 to September 2015. The company has instructed to stop distribution of the 3 lots immediately and arrange for return to Stericycle by calling (866) 367-5604. No other lots are being recalled at this time. Potentially affected pharmacies have been issued recall communications by AstraZeneca.
Tudorza Pressair is an anticholinergic indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disorder (COPD), including chronic bronchitis and emphysema.
It is supplied as 400mcg per actuation dry powder inhaler containing a total of 60 doses.
For more information call (800) 237-8898 or visit Tudorza.com.