Recalls / Class II
Class IID-0841-2018
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
- Brand name
- Fluticasone Propionate
- Generic name
- Fluticasone Propionate
- Active ingredient
- Fluticasone Propionate
- Route
- Nasal
- NDC
- 60505-0829
- FDA application
- ANDA077538
- Affected lot / code info
- Lot: NJ4501 Exp. 07/2020
Why it was recalled
Presence of foreign substance: glass particles
Recalling firm
- Firm
- Apotex Inc.
- Manufacturer
- Apotex Corp.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Dr, N/A, North York, N/A N/A, Canada
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-05-31
- FDA classified
- 2018-06-06
- Posted by FDA
- 2018-06-13
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0841-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.