Exact FDA event identifier

Event 79036

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

Event summary

Timeline bucket: January 19, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AMERICAN HEALTH PACKAGING

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

Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.

D-0595-2018

Recall number: D-0595-2018
Initiated: January 19, 2018
Classification: Class II
Status: Terminated
Recalling firm: AMERICAN HEALTH PACKAGING
Quantity: 270 cartons

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Code information

Lot #: 174096, Exp 05/31/19

Distribution pattern

Nationwide in the USA