FDA Recall D-0326-2024
Apotex Corp. · Weston, FL
Class II Ongoing 825 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Recall record
- Recall number
D-0326-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2024-02-09
- Classified by FDA Center
- 2024-02-16
- FDA published
- 2024-02-28
- Recalling firm
- Apotex Corp.
- Firm location
- Weston, FL
Drug identification
- Brand name(s)
- FLUTICASONE PROPIONATE
- Generic name(s)
- FLUTICASONE PROPIONATE
- Manufacturer(s)
- Apotex Corp.
- NDC(s)
60505-0829- Route(s)
- NASAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.