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Recall Observatory FDA recall evidence

Drug 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.

D-064-2013

October 24, 2012

Class III

Product summary

Firm
GlaxoSmithKline, LLC.
Event
Event 63707
Status
Terminated
Classification
Class III
Quantity
310,964 Aerosol Units
Official record key
drug-enforcement:D-064-2013

Official wording

Reason: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.

Code information: 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.

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.