D-0841-2018 Class II Terminated
FDA drug recall D-0841-2018 was initiated by Apotex Inc. on May 31, 2018 and is designated Class II. Reason for recall: Presence of foreign substance: glass particles The recall status is terminated (terminated Sep 28, 2022).
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 13, 2018
- Initiation Date
- May 31, 2018
- Termination Date
- Sep 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot: NJ4501 Exp. 07/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0841-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026