Drug 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.
D-1279-2015
Product summary
- Event
- Event 71760
- Status
- Terminated
- Classification
- Class II
- Quantity
- 358,647 inhalers
- Official record key
drug-enforcement:D-1279-2015
Official wording
Reason: Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Code information: Lot #: 408267, Exp 11/17
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.