Enforcement Report - Week of December 5, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | 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. | Class III | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | 310,964 Aerosol Units | D-064-2013 |
| 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. | 1ZP3065, Exp. Oct-12, 1ZP5453, Exp. Dec-12, 1ZP3315, Exp. May-13, 2ZP9974, Exp. Sep-13. | Class III | Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. | 18,676 Aerosol Units | D-065-2013 |
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