FDA recall D-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

Reason for recall

Presence of foreign substance: glass particles

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-05-31

Report date

2018-06-13

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

North York, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0841-2018