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.
Reported: August 5, 2015 Initiated: July 24, 2015 #D-1279-2015
Product Description
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.
Details
- Recalling Firm
- Boehringer Ingelheim Roxane Inc
- Units Affected
- 358,647 inhalers
- Distribution
- Nationwide and Puerto Rico
- Location
- Columbus, OH
Frequently Asked Questions
What product 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.. Recalled by Boehringer Ingelheim Roxane Inc. Units affected: 358,647 inhalers.
Why was this product recalled? ▼
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 5, 2015. Severity: Moderate. Recall number: D-1279-2015.
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