Exact FDA event identifier

Event 71732

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

Event summary

Timeline bucket: July 13, 2015
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Purdue Pharma L.P.

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

D-1278-2015

Recall number: D-1278-2015
Initiated: July 13, 2015
Classification: Class III
Status: Terminated
Recalling firm: Purdue Pharma L.P.
Quantity: 6,264 cartons (30 sublingual tablets in 1 carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed dissolution specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications

Code information

Lot # 3122833A, Expiry 5/31/16

Distribution pattern

Nationwide and Puerto Rico