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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95701

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

Open FDA event record

Event summary

Timeline bucket
October 31, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Noven 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

Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3

D-0055-2025
Recall number
D-0055-2025
Initiated
October 31, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Noven Pharmaceuticals Inc
Quantity
685 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

Code information

Lot # 95598, Exp 02/28/25

Distribution pattern

USA nationwide.