FDA Recall D-0349-2024

Golden State Medical Supply Inc. · Camarillo, CA

Class II Ongoing 820 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

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

Quantity: 59,712 bottles

Reason for recall

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Recall record

Recall number: D-0349-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-02-14
Classified by FDA Center: 2024-02-23
FDA published: 2024-03-06
Recalling firm: Golden State Medical Supply Inc.
Firm location: Camarillo, CA

Drug identification

Brand name(s): FLUTICASONE PROPIONATE
Generic name(s): FLUTICASONE PROPIONATE
Manufacturer(s): Golden State Medical Supply, Inc.
NDC(s): 60429-195
Route(s): NASAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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