GlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues
GlaxoSmithKline is recalling 18,676 units 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure (particle size) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
GlaxoSmithKline, LLC. is recalling 18,676 units of Advair HFA (fluticasone propionate and salmeterol xinafoate) inhalation aerosol. The product is a prescription medication used for respiratory conditions. The recall was initiated because the affected lots failed to meet the particle size distribution specification, which is a stability requirement for the product.
The recalled product is distributed nationwide and in Puerto Rico. Specific lot codes and expiration dates are listed in the recall notice, including lots expiring in October 2012, December 2012, May 2013, and September 2013. The FDA has classified this recall as Class III, indicating that the violation is not likely to cause adverse health consequences.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on replacement or disposal. The recall is limited to the specific lots identified in the official 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
- 18,676
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 (8)
- 1ZP3065
- Exp. Oct-12
- 1ZP5453
- Exp. Dec-12
- 1ZP3315
- Exp. May-13
- 2ZP9974
- Exp. Sep-13.
Distribution
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
- LowGlaxoSmithKline Recalls Advair HFA Inhalers Due to Particle Size Issues
FDA (Drugs) · 2012-12-05
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