FDA recall D-0349-2024

Golden State Medical Supply Inc. · Class II · drug

Product

Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15

Reason for recall

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2024-02-14
Report date: 2024-03-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0349-2024