Reported Aug 5, 2015 · Terminated

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120…

Boehringer Ingelheim Roxane Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boehringer Ingelheim Roxane Inc · 1809 Wilson Rd · Columbus, OH · 43228-9579

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot #: 408267
    • Exp 11/17
Amount recalled
358,647 inhalers

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 1, 2017 · Data as of Sep 19, 5:54 PM UTC

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