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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63095

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

Open FDA event record

Event summary

Timeline bucket
August 28, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dispensing Solutions, 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

Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947

D-1691-2012
Recall number
D-1691-2012
Initiated
August 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
Dispensing Solutions, Inc
Quantity
18 Inhalers

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Label Mix up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol

Code information

Lot # F23989, F22311

Distribution pattern

US: IN & WI

Field note

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