Exact FDA event identifier

Event 64118

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

Open FDA event record

Event summary

Timeline bucket: January 22, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Sandoz Incorporated

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

Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ

D-152-2013

Recall number: D-152-2013
Initiated: January 22, 2013
Classification: Class III
Status: Terminated
Recalling firm: Sandoz Incorporated
Quantity: 17,188 cartons containing 3 cards each.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

Code information

LF01215A, Exp 02/2014

Distribution pattern

Nationwide