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,

FDA recall notice · announced August 5, 2015 · Boehringer Ingelheim Roxane

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 408267, Exp 11/17
Quantity: 358,647 inhalers
Status: Terminated
Products in this recall event:
- 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 Pharmaceuti (D-1279-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.