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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93974

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

Open FDA event record

Event summary

Timeline bucket
February 09, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Apotex Corp.

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

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

D-0326-2024
Recall number
D-0326-2024
Initiated
February 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Apotex Corp.
Quantity
292,752 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations
Microbial contamination reason.microbial_contamination · v1.0.0
presence of Burkholderia cepacia

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: potential presence of Burkholderia cepacia complex

Code information

Lot number # TX5274 Exp. 09/30/2026

Distribution pattern

Nationwide in the USA