FDA Drug recall D-0326-2024
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc
- FDA Drug
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc by Apotex, citing CGMP Deviations: potential presence of Burkholderia cepacia complex.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0326-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-09 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
CGMP Deviations: potential presence of Burkholderia cepacia complex
Identifiers
| ndc | 60505-0829-1 |
|---|---|
| code_info | Lot number # TX5274 Exp. 09/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0326-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.