Fluticasone Propionate Nasal Spray USP 50mcg — Class II drug recall D-0326-2024
Ongoing recall by Apotex Corp., reported 2024-02-28, distributed nationwide. CGMP Deviations: potential presence of Burkholderia cepacia complex
| Recall number | D-0326-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2024-02-09 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 292,752 bottles |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| NDC | 60505-0829-01 |
| Lot numbers | TX5274 |
| Expiration dates | 2026-09-30 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0326-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.