FDA recall D-0781-2016

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.

Distribution

US: Nationwide Including Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-02-05

Report date

2016-03-30

Termination date

2017-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilmington, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0781-2016