Exact FDA event identifier

Event 69246

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

Event summary

Timeline bucket: September 15, 2014
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Astellas Pharma US 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

Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01

D-0008-2015

Recall number: D-0008-2015
Initiated: September 15, 2014
Classification: Class II
Status: Terminated
Recalling firm: Astellas Pharma US Inc
Quantity: 9,236 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.

Code information

Lot 66482CW, Exp 04/16

Distribution pattern

Nationwide