Exact FDA event identifier

Event 80202

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

Event summary

Timeline bucket: May 31, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Apotex 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

Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1

D-0841-2018

Recall number: D-0841-2018
Initiated: May 31, 2018
Classification: Class II
Status: Terminated
Recalling firm: Apotex Inc.
Quantity: Unknown

App-derived interpretation

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

foreign substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of foreign substance: glass particles

Code information

Lot: NJ4501 Exp. 07/2020

Distribution pattern

Nationwide