Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: TX5275, Exp. Date: 10/31/2026.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0349-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 14, 2024
- FDA report date
- Mar 6, 2024
- Quantity
- 59,712 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0349-2024, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 94029
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: TX5275, Exp. Date: 10/31/2026.
- Postal code
- 93012-8601
- Report date
- Mar 6, 2024
- Product type
- Drugs
- Recall number
- D-0349-2024
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 59,712 bottles
- Reason for recall
- CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Feb 14, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2024