What Are Some Facts About the Combivent Respimat Recall?


Quick Answer

The Combivent Respimat recall was issued on July 24, 2015, covering a single manufacturing lot of 358,647 inhalers used to treat Chronic Obstructive Pulmonary Disease, or COPD, according to the U.S. Food and Drug Administration. The action was a voluntary recall initiated by the manufacturer, Boehringer Ingelheim Roxane Inc, to recover the faulty units. The inhalers were produced in Germany and then distributed throughout the United States in April 2015.

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Full Answer

Each 4-gram inhaler of Combivent Respimat should contain 120 metered doses, but the FDA advises that the defective lot of inhalers does not function properly, either emitting a short spray with an improper dose or no spray at all. The recall is listed as a class II recall, in which use of the inhaler could cause short-lived or reversible consequences to a patient’s health, but serious medical consequences are unlikely.

The recalled medication is a pocket-sized, propellant-free inhaler containing a combination of ipratropium bromide and albuterol, as outlined by Monthly Prescribing Reference. Combivent Respimat is indicated in the treatment of COPD for maintenance of the disease or when a second bronchodilator is medically necessary. Bronchodilators are used to help open the airways of individuals with COPD to allow for more air flow and to lessen breathing difficulties, states MedlinePlus.

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