Golden State Medical Supply Inc.: Drug Recall

Recall #D-0349-2024 · 02/14/2024

Class II: Risk

Recall Details

Recall Number: D-0349-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Golden State Medical Supply Inc.
Status: Ongoing
Date Initiated: 02/14/2024
Location: Camarillo, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 59,712 bottles

Reason for Recall

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Golden State Medical Supply Inc.

Class II: Risk 11/26/2025

Presence of Foreign Tablets/Capsules
Class II: Risk 10/20/2025

Failed Dissolution Specifications
Class II: Risk 03/05/2025

Failed Dissolution Specifications
Class II: Risk 05/13/2024

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Class II: Risk 01/12/2024

Failed Dissolution Specifications

View all recalls by Golden State Medical Supply Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.