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
Reported: February 28, 2024 Initiated: February 9, 2024 #D-0326-2024
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
Reason for Recall
CGMP Deviations: potential presence of Burkholderia cepacia complex
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 292,752 bottles
- Distribution
- Nationwide in the USA
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 292,752 bottles.
Why was this product recalled? ▼
CGMP Deviations: potential presence of Burkholderia cepacia complex
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2024. Severity: Moderate. Recall number: D-0326-2024.
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