FDA Drug recall D-064-2013
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with…
- FDA Drug
- Class III
- terminated
- Published 2012-12-05
On 2012-12-05 the FDA classified a Class III recall of Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with… by Glaxosmithkline, citing product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-064-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-24 |
| Published | 2012-12-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Glaxosmithkline |
| Distribution | US |
Product
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.
Reason
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Identifiers
| ndc | 0173-0715-20 |
|---|---|
| ndc | 0173-0715-22 |
| ndc | 0173-0716-20 |
| ndc | 0173-0716-22 |
| ndc | 0173-0717-20 |
| ndc | 0173-0717-22 |
| code_info | Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900,…Lot #: 1ZP2465, Exp Oct-12, 1ZP5224, Exp. Nov-12, 1ZP5455, 1ZP6916, Exp. Dec-12, 1ZP8042, 1ZP9593, Exp Jan-13, 1ZP9900, Exp. Mar-13, 1ZP1134, Exp. Apr-13, 1ZP3190, 2ZP6531, Exp. May-13, 2ZP6924, 2ZP7258, Exp. Jul-13, 2ZP1886, 2ZP9975, 2ZP0027, 2ZP9782, Exp. Sep-13, 2ZP1331, Exp. Oct-13, 2ZP2366, Exp. Nov-13. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-064-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.