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

Recall date

July 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1279-2015

FDA classification

Class II

Brand / firm

Boehringer Ingelheim Roxane Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.