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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66791

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

Open FDA event record

Event summary

Timeline bucket
November 06, 2013
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sandoz 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

Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05

D-341-2014
Recall number
D-341-2014
Initiated
November 06, 2013
Classification
Class III
Status
Terminated
Recalling firm
Sandoz Inc
Quantity
11,496 bottles (100 count) and 62 bottles (500 count)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

Code information

Lot #: a) CU6131, b) CW1161

Distribution pattern

Nationwide