Advair HFA — Class III drug recall D-064-2013
Terminated recall by GlaxoSmithKline, LLC., reported 2012-12-05, distributed nationwide. Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distributi
| Recall number | D-064-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GlaxoSmithKline, LLC., Zebulon, NC, United States |
| Recall initiated | 2012-10-24 |
| Classified | 2012-11-23 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 310,964 aerosol |
| Reason classes | specification failure |
| NDC | 00173-0715, 00173-0715-20, 00173-0715-22, 00173-0716, 00173-0716-20, 00173-0716-22, 00173-0717, 00173-0717-20, 00173-0717-22 |
| Lot numbers | 1ZP1134, 1ZP2465, 1ZP3190, 1ZP5224, 1ZP5455, 1ZP6916, 1ZP8042, 1ZP9593, 1ZP9900, 2ZP0027, 2ZP1331, 2ZP1886, 2ZP2366, 2ZP6531, 2ZP6924, 2ZP7258, 2ZP9782, 2ZP9975, APR-13, DEC-12, JAN-13, JUL-13, MAR-13, MAY-13, NOV-12, NOV-13, OCT-12, OCT-13, SEP-13 |
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 for recall
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-064-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.