Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | D-064-2013 |
| Classification | Class III |
| Code Info | 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. |
| Product Distributed Qty | 310,964 Aerosol Units |
| Reason For Recall | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. |
Event Detail
| Event Id | 63707 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | GlaxoSmithKline, LLC. |
| City | Zebulon |
| State | NC | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico. |
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