February 2016 FDA Recall Drug by Astrazeneca Pharmaceuticals Lp
D-0781-2016 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Astrazeneca Pharmaceuticals Lp on February 5, 2016 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0781-2016

Reason for Recall
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Initiated
02-05-2016
Reported
03-30-2016
Quantity
148,331 Inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73538
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AstraZeneca Pharmaceuticals LP
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US: Nationwide Including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-20-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 1144394, Expiry: 04/2018
Lot# 1145539, Expiry: 04/2018
Lot# 1145868, Expiry: 05/2018.