Exact FDA event identifier

Event 63906

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

Open FDA event record

Event summary

Timeline bucket: December 13, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Watson Laboratories 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

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.

D-094-2013

Recall number: D-094-2013
Initiated: December 13, 2012
Classification: Class III
Status: Terminated
Recalling firm: Watson Laboratories Inc
Quantity: 63,627 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.

Code information

432127A Exp. 01/13, 478076A Exp. 05/13, 515539B Exp.09/13

Distribution pattern

Nationwide