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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81189

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

Open FDA event record

Event summary

Timeline bucket
October 05, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Amerigen 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

Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.

D-0249-2019
Recall number
D-0249-2019
Initiated
October 05, 2018
Classification
Class III
Status
Terminated
Quantity
5,232 bottles: a) 4,146 bottles; b) 1,086 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 dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

Code information

Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19

Distribution pattern

Product was distributed U.S. nationwide.