The Recall Desk
LowFDA (Drugs)·D-064-2013·Announced 2012-12-05

GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues

GlaxoSmithKline is recalling specific lots of Advair HFA inhalers because they failed to meet particle size distribution specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

GlaxoSmithKline, LLC. is recalling 310,964 units of Advair HFA (fluticasone propionate and salmeterol xinafoate) inhalation aerosol. The recall involves specific lots distributed nationwide and in Puerto Rico.

The recall was initiated because the affected lots failed to meet the particle size distribution specification. This is a Class III recall, which the FDA defines as a situation where use of, or exposure to, a violative product is not likely to cause adverse health consequences.

Consumers with the affected lots should stop using the product and contact their healthcare provider or pharmacist for a replacement. The specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
ADVAIR HFA (FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE)
Brand
ADVAIR HFA
Manufacturer
GlaxoSmithKline, LLC.
Category
Drug — Inhalation Aerosol
Hazard
Affected units
310,964

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by GlaxoSmithKline, LLC. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · ADVAIR HFA

Same manufacturer · GlaxoSmithKline, LLC.

See all →