Recall: COPD Inhaler Combivent Respimat

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer Boehringer Ingelheim has issued a voluntary recall of one lot of Combivent Respimat, a popular COPD inhaler. Combivent Respimat is a maintenance inhaler used to help keep airways open to make breathing easier for patients with COPD. It’s made up of a combination of two active ingredients, ipratropium and albuterol.

This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

The manufacturer can voluntarily recall their medication or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled one lot of the only available strength (1.1% or 20mcg/100mcg per actuation) of the Combivent Respimat inhaler.

Why is the Combivent Respimat inhaler being recalled?

The recall was initiated because some Combivent Respimat devices from this lot are not spraying properly. They may not spray at all, or may only give a shorter spray than normal, meaning you wouldn’t get the right amount of medication per dose.

When was the recall initiated?

The affected lot of Combivent Respimat inhalers were recalled by the manufacturer on July 24, 2015.

How long have the affected products been in pharmacies?

Not too long in this case. The recalled lot of Combivent Respimat inhalers started shipping about three months ago, on April 15, 2015.

Are patients who have taken this medication being notified?

No. This is a class II recall, which means that notification of patients is not necessary unless your doctor believes it may have an effect on your health.

If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.

Which products were affected?

In this recall, just one lot was affected:

Drug: Combivent Respimat, 120 dose inhaler (20mcg/100mcg per actuation)
Manufacturer: Boehringer Ingelheim
Lot: 408267, expiration 11/30/2017
National Drug Code (NDC): 00597-0024-02

There is only one strength and NDC for the Combivent Respimat inhaler, so you’ll want to check the lot number and expiration to see if your inhaler is affected by the recall.

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