Fluticasone propionate Nasal Spray — Class II drug recall D-0841-2018
Terminated recall by Apotex Inc., reported 2018-06-13, distributed nationwide. Presence of foreign substance: glass particles
| Recall number | D-0841-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, N/A, Canada |
| Recall initiated | 2018-05-31 |
| Classified | 2018-06-06 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material |
| NDC | 60505-0829-01 |
| Lot numbers | NJ4501 |
| Expiration dates | 2020-07 |
Product
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, 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
Presence of foreign substance: glass particles
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-0841-2018. 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.