Fluticasone Propionate Nasal Spray USP…

Date

March 6, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Golden State Medical Supply Inc.

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

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Distribution pattern

Nationwide in the USA

Quantity

59,712 bottles

Codes and lots

Lot #: TX5275, Exp. Date: 10/31/2026.

Recall started

Feb. 14, 2024

Recall number

D-0349-2024

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0349-2024. The agency record governs; check it and the company before acting.