Drug 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
D-0841-2018
Product summary
- Firm
- Apotex Inc.
- Event
- Event 80202
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0841-2018
Official wording
Reason: Presence of foreign substance: glass particles
Code information: Lot: NJ4501 Exp. 07/2020
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance