Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Advair HFA
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0715-20.
Affected NDC
0173-0715-20
Compare with the code on your package — it is the most precise check available.
Drug: Fluticasone Category: Allergy & Cold Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Advair Hfa fluticasone propionate and salmeterol xinafoate NDC 00173-0715 |
FLUTICASONE PROPIONATE 45 ug/1; SALMETEROL XINAFOATE 21 ug/1 | Aerosol, Metered Respiratory (inhalation) |
GlaxoSmithKline LLC | Rx |
- Recalling firm
- GlaxoSmithKline, LLC.
- NDC code
- 0173-0715-20
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-064-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fluticasone recalls
See all
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by GlaxoSmithKline, LLC.
All 2012 recalls
Class III · Low risk
Tivicay PD
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk
Anoro Ellipta
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class III · Low risk
Tivicay (dolutegravir)
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class II · Moderate risk
Ventolin HFA
Defective Delivery System: Elevated number of units with out of specification results for leak rate
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