Boehringer Ingelheim Roxane Inc recalls COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg per actuation*, 4 Grams, 120 Met

Recalled August 5, 2015 · FDA recall D-1279-2015 · Boehringer Ingelheim Roxane

Hazard

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

Units

358,647 inhalers

Sold at

Nationwide and Puerto Rico

Description

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

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.

Manufacturer(s)

Boehringer Ingelheim Roxane Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →