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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71760

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 24, 2015
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boehringer Ingelheim Roxane Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-1279-2015
Recall number
D-1279-2015
Initiated
July 24, 2015
Classification
Class II
Status
Terminated
Quantity
358,647 inhalers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.

Code information

Lot #: 408267, Exp 11/17

Distribution pattern

Nationwide and Puerto Rico