GlaxoSmithKline, LLC.: 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, Gla

Is my product affected?

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.

• Brand ADVAIR HFA

Check against the official notice below — it lists the full affected range.

What happened

GlaxoSmithKline is recalling 310,964 units of Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) inhalation aerosol nationwide and in Puerto Rico. The recall affects multiple lot numbers with expiration dates ranging from October 2012 through November 2013 because these lots failed to meet the particle size distribution specification, which affects product stability.

The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. Distribution: Nationwide and Puerto Rico. Quantity: 310,964 Aerosol Units Lot/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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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