Why it was recalled
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
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.
Lot numbers, UPCs & expiration codes
Lot #: 408267, Exp 11/17
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1279-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2015
- FDA report date
- Aug 5, 2015
- Quantity
- 358,647 inhalers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Roxane Inc
Original FDA data
Every field from FDA enforcement report D-1279-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 71760
- Address
- 1809 Wilson Rd
- Code information
- Lot #: 408267, Exp 11/17
- Postal code
- 43228-9579
- Report date
- Aug 5, 2015
- Product type
- Drugs
- Recall number
- D-1279-2015
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Product quantity
- 358,647 inhalers
- Termination date
- Feb 1, 2017
- Reason for recall
- Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 24, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 27, 2015