Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Defective container: defect prevents product from dispensing as intended.
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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