Combivent Respimat Spray, Metered
FDA Recall NDC 0597-0024
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Combivent Respimat (NDC 0597-0024). A significant event, classified as Class II, was initiated on Jul 24, 2015 by Boehringer Ingelheim Pharmaceuticals, Inc.. The reported reason for this action was: "Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Jul 24, 2015
Aug 05, 2015
358,647 inhalers
Recall Profile & Regulatory Data
Event ID
71760
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Feb 01, 2017
Product Description
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
0597-0024-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
