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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70764

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

Open FDA event record

Event summary

Timeline bucket
February 25, 2015
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

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

Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8

D-0485-2015
Recall number
D-0485-2015
Initiated
February 25, 2015
Classification
Class II
Status
Terminated
Quantity
720 transdermal patches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Code information

Lot # 76476; Exp 07/16

Distribution pattern

Nationwide