Exact FDA event identifier

Event 90162

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

Event summary

Timeline bucket: May 06, 2022
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

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) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3

D-0889-2022

Recall number: D-0889-2022
Initiated: May 06, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Noven Pharmaceuticals Inc
Quantity: 274, 110 patches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Delivery System: customer complaints exceeded respective action limits.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: customer complaints exceeded respective action limits.

Code information

Lot: 90764 Exp. 08/2022

Distribution pattern

Nationwide to the U.S. Market