COMBIVENT RESPIMAT — Class II drug recall D-1279-2015
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2015-08-05, distributed nationwide. Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray
| Recall number | D-1279-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2015-07-24 |
| Classified | 2015-07-27 |
| Reported by FDA | 2015-08-05 |
| Terminated | 2017-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 358,647 inhalers |
| NDC | 00597-0024, 00597-0024-02 |
| Lot numbers | 11/17, 408267 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1279-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.