Why it was recalled
CGMP Deviations: potential presence of Burkholderia cepacia complex
Product description
Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Lot numbers, UPCs & expiration codes
Lot number # TX5274 Exp. 09/30/2026
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-0326-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 9, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 292,752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0326-2024, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 93974
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot number # TX5274 Exp. 09/30/2026
- Postal code
- 33326-3253
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0326-2024
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 292,752 bottles
- Reason for recall
- CGMP Deviations: potential presence of Burkholderia cepacia complex
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2024