Exact FDA event identifier

Event 81068

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

Open FDA event record

Event summary

Timeline bucket: September 21, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals USA

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

Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.

D-0001-2019

Recall number: D-0001-2019
Initiated: September 21, 2018
Classification: Class II
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Quantity: 313 bottles

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

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

Code information

Lot #: 34034024B, Exp 02/20

Distribution pattern

Distributed nationwide in the USA