CLASS II Drug recall · Reported 5 Aug 2015 · FDA Enforcement Report
Combivent Respimat (ipratropium bromide recalled
Boehringer Ingelheim Roxane is recalling Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray, 20 mcg/100 mcg, distributed nationwide in the US. The recall was initiated on 24 Jul 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1279-2015
- FDA event ID
- 71760
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Combivent Respimat
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2015
- FDA classified
- 27 Jul 2015
- Reported
- 5 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 24 Jul 2015 | Recall initiated by company | |
| 27 Jul 2015 | Classified by FDA | +3 days |
| 5 Aug 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Which lots are affected?
Lot #: 408267, Exp 11/17
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Ipratropium recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate | Cipla USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Ipratropium Bromide and Albuterol Sulfate Inhalation recalledIpratropium Bromide And Albuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg recalledIpratropium Bromide | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg recalledIpratropium Bromide And Albuterol Sulfate | Nephron Pharmaceuticals | Sterility | Nationwide |