Exact FDA event identifier

Event 76495

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

Open FDA event record

Event summary

Timeline bucket: February 16, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Allegiant Health

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

HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729

D-0500-2017

Recall number: D-0500-2017
Initiated: February 16, 2017
Classification: Class II
Status: Terminated
Recalling firm: Allegiant Health
Quantity: 70,176 bottles; 9,000,000 tablets (bulk)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

rubber particles

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 - presence of rubber particles found loose in the bulk product.

Code information

Lot # 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)

Distribution pattern

Nationwide