Home / Recalls / Apotex Corp. / D-0326-2024

D-0326-2024 Class II Ongoing

Recalled by Apotex Corp. — Weston, FL

FDA drug recall D-0326-2024 was initiated by Apotex Corp. on Feb 9, 2024 and is designated Class II. Reason for recall: CGMP Deviations: potential presence of Burkholderia cepacia complex The recall status is ongoing. Affected quantity: 292,752 bottles.

Recall details

Product Type: Drugs
Report Date: Feb 28, 2024
Initiation Date: Feb 9, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 292,752 bottles

Product description

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

Reason for recall

CGMP Deviations: potential presence of Burkholderia cepacia complex

Distribution pattern

Nationwide in the USA

Code information

Lot number # TX5274 Exp. 09/30/2026

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0326-2024
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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