Multi event Drug Recall Enforcement Report Class III voluntary initiated by GlaxoSmithKline, LLC., originally initiated on 10-24-2012 for the product Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. The product was recalled due to product lacks stability: these lots are being recalled due to the failure to meet the particle size distribution specification.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-065-2013 | 10-24-2012 | 12-05-2012 | Class III | 18,676 Aerosol Units | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | Terminated |
| D-064-2013 | 10-24-2012 | 12-05-2012 | Class III | 310,964 Aerosol Units | 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. | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0173-0715 | Advair Hfa | Fluticasone Propionate And Salmeterol Xinafoate | Aerosol, Metered | Respiratory (inhalation) | Glaxosmithkline Llc | Human Prescription Drug |
| 0173-0716 | Advair Hfa | Fluticasone Propionate And Salmeterol Xinafoate | Aerosol, Metered | Respiratory (inhalation) | Glaxosmithkline Llc | Human Prescription Drug |
| 0173-0717 | Advair Hfa | Fluticasone Propionate And Salmeterol Xinafoate | Aerosol, Metered | Respiratory (inhalation) | Glaxosmithkline Llc | Human Prescription Drug |
