Recalls / Class II
Class IID-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.
- Brand name
- Combivent Respimat
- Generic name
- Ipratropium Bromide And Albuterol
- Active ingredients
- Albuterol Sulfate, Ipratropium Bromide
- Route
- Respiratory (inhalation)
- NDC
- 0597-0024
- FDA application
- NDA021747
- Affected lot / code info
- Lot #: 408267, Exp 11/17
Why it was recalled
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 358,647 inhalers
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-07-24
- FDA classified
- 2015-07-27
- Posted by FDA
- 2015-08-05
- Terminated
- 2017-02-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1279-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.