Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
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.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.