Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 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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