Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Fluticasone propionate USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
What was recalled
Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Recalling firm
- American Pharmaceutical Ingredients LLC
- NDC code
- 58597-8276-3
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0539-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Fluticasone recalls
See all
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray USP 50mcg
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk Ongoing
Fluticasone Propionate Nasal Spray
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Terminated
Fluticasone Propionate Nasal Spray
Reason Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk Terminated
Inhub Wixela
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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