PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: March 6, 2024 Initiated: February 14, 2024 #D-0349-2024

Product Description

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

Details

Units Affected
59,712 bottles
Distribution
Nationwide in the USA
Location
Camarillo, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Golden State Medical Supply Inc.. Units affected: 59,712 bottles.
Why was this product recalled?
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Which agency issued this recall?
This recall was issued by the FDA Drug on March 6, 2024. Severity: Moderate. Recall number: D-0349-2024.