FDA recall D-1279-2015

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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2015-07-24

Report date

2015-08-05

Termination date

2017-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1279-2015