July 2015 FDA Recall Combivent Respimat by Boehringer Ingelheim Roxane Inc
D-1279-2015 - Defective Delivery System

This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Roxane Inc on July 24, 2015 for the product Combivent Respimat. 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-1279-2015

Reason for Recall
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Initiated
07-24-2015
Reported
08-05-2015
Quantity
358,647 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71760
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.
Boehringer Ingelheim Roxane Inc
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-01-2017
Product Description About Product Description
Full technical description of the product.
COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Metered Doses per inhaler, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0024-02.

Batch or Lot Expiration Information

Lot# : 408267, Exp 11/17

Affected Packages Involved in this Recall

0597-0024-02 Combivent Respimat