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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78775

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

Open FDA event record

Event summary

Timeline bucket
December 14, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boehringer Ingelheim Pharmaceuticals, 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

SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47

D-0242-2018
Recall number
D-0242-2018
Initiated
December 14, 2017
Classification
Class II
Status
Terminated
Quantity
45,008 units/90 capsules each unit

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Stability Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications

Code information

Lot # 606478; Exp. 03/18

Distribution pattern

Distributed nationwide