Exact FDA event identifier

Event 62002

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

Open FDA event record

Event summary

Timeline bucket: March 22, 2012
Product types: Drug
Classifications: Class II
Statuses: Terminated
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

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

Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

D-1413-2012

Recall number: D-1413-2012
Initiated: March 22, 2012
Classification: Class II
Status: Terminated
Recalling firm: Noven Pharmaceuticals, Inc.
Quantity: 185,160 patches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

Code information

Lot # 53995

Distribution pattern

Nationwide and Puerto Rico