FDA recall D-0326-2024

Apotex Corp. · Class II · drug

Product

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

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2024-02-09
Report date: 2024-02-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0326-2024